6 Associate Director, Quality Operations Jobs in Boulder, CO
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Associate Director, Quality Operations
$191k-232k (estimate)
Full Time | Durable Manufacturing
3 Weeks Ago
Corden Pharma - A Full-Service CDMO is Hiring an Associate Director, Quality Operations Near Boulder, CO
EQUAL OPPORTUNITY EMPLOYER Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.
CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.
Our network in Europe and the U.S. offers flexible and specialized solutions across six technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; Oligonucleotides and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.
SummaryResponsible for the Site Quality Assurance Operational Unit, including main Customer Program QA Point of Contact, Deviation and CAPA Management, Batch Record Release & Review, and Shop Floor QA Oversight.
The head of QA Operations is responsible for leading, developing, and engaging the Site QA Operations Team to ensure successful customer project delivery.
Provides leadership for the Quality Operations in accordance with directions from the Director of Quality Assurance and Control based on the organization's policies, applicable laws, and guidance.
Quality and compliance activities to include the direction of all related operations pertaining to release activities (QA), and continuous improvement (including inspection readiness for all manufacturing and operational areas).
The Associate Director is responsible for ensuring that adequate resources are retained, trained, qualified, validated, and deployed timely to ensure compliant material is released per site schedules.
Ensures cGMP throughout the product life cycle is maintained and compliant with company quality and compliance policies, and practices based on applicable regulation and guidance.
Responsibilities include goal alignment with the Director of Quality Assurance and Control. Goal realization includes achievement consistent with site strategy, developing employees; planning, assigning, and managing work; and continuous improvement, addressing complaints and resolving problems.
Participates directly in customer and government quality audits and inquiries from a quality operational perspective; meaning in regard to material production, deviation resolutions, risk documentation, and release decisions.
Designee to Corden Pharma Colorado’s (CPC) site Leadership Team.
Designee to the site Quality Council.
Inspection ReadinessResponsible for ensuring functional site cGMP Inspection Readiness Programs are established in the product life cycle and executed in collaboration with business unit. Ensure allocation of the necessary site resources to successfully execute the program in all functions across the site.
Product Quality ManagementResponsible for Product Quality Management activities to include change management, investigation and CAPA management, product field performance (complaint management), and product performance trending, and reporting for site consistent with customer quality agreements. Direct and participate in site level continuous improvement initiatives related to operational impacts, including their quality and regulatory requirements. Manage and drive operational unity Quality metrics within the site to SOP requirements, expectations, and goals. Ensure timely reporting of metrics and remediation plans are in place where metrics do not meet target.
Budgeting and Financial PerformanceAccountable for operational budget and financial performance of the site Quality Operations Organization.
Essential Duties And ResponsibilitiesInclude the following. Other duties may be assigned.
Leadership & Budget ResponsibilitiesProvides guidance and leadership for the department. Contributes to the direction and oversight of the operational aspects of Corden Pharma Colorado by advising the site Operating Committee.
Safety & Environmental ResponsibilitiesEvery individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.
QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION And/or EXPERIENCEBachelor's Degree from college or university; and 10 years of related experience; or equivalent combination of education and experience.
Language SkillsAbility to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.
Mathematical SkillsAbility to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
REASONING ABILITYAbility to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent, and to draw and interpret bar graphs.
CERTIFICATES, LICENSES, REGISTRATIONSNone.
PHYSICAL DEMANDSThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit; work with hands; and talk or hear. The employee is occasionally required to stand; walk; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include ability to adjust focus.
WORK ENVIRONMENTThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, and noise typical of an office environment.
CORE COMPETENCIESThese are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.
Benefits
CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.
Our network in Europe and the U.S. offers flexible and specialized solutions across six technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; Oligonucleotides and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.
SummaryResponsible for the Site Quality Assurance Operational Unit, including main Customer Program QA Point of Contact, Deviation and CAPA Management, Batch Record Release & Review, and Shop Floor QA Oversight.
The head of QA Operations is responsible for leading, developing, and engaging the Site QA Operations Team to ensure successful customer project delivery.
Provides leadership for the Quality Operations in accordance with directions from the Director of Quality Assurance and Control based on the organization's policies, applicable laws, and guidance.
Quality and compliance activities to include the direction of all related operations pertaining to release activities (QA), and continuous improvement (including inspection readiness for all manufacturing and operational areas).
The Associate Director is responsible for ensuring that adequate resources are retained, trained, qualified, validated, and deployed timely to ensure compliant material is released per site schedules.
Ensures cGMP throughout the product life cycle is maintained and compliant with company quality and compliance policies, and practices based on applicable regulation and guidance.
Responsibilities include goal alignment with the Director of Quality Assurance and Control. Goal realization includes achievement consistent with site strategy, developing employees; planning, assigning, and managing work; and continuous improvement, addressing complaints and resolving problems.
Participates directly in customer and government quality audits and inquiries from a quality operational perspective; meaning in regard to material production, deviation resolutions, risk documentation, and release decisions.
Designee to Corden Pharma Colorado’s (CPC) site Leadership Team.
Designee to the site Quality Council.
Inspection ReadinessResponsible for ensuring functional site cGMP Inspection Readiness Programs are established in the product life cycle and executed in collaboration with business unit. Ensure allocation of the necessary site resources to successfully execute the program in all functions across the site.
Product Quality ManagementResponsible for Product Quality Management activities to include change management, investigation and CAPA management, product field performance (complaint management), and product performance trending, and reporting for site consistent with customer quality agreements. Direct and participate in site level continuous improvement initiatives related to operational impacts, including their quality and regulatory requirements. Manage and drive operational unity Quality metrics within the site to SOP requirements, expectations, and goals. Ensure timely reporting of metrics and remediation plans are in place where metrics do not meet target.
Budgeting and Financial PerformanceAccountable for operational budget and financial performance of the site Quality Operations Organization.
Essential Duties And ResponsibilitiesInclude the following. Other duties may be assigned.
- Quality Risk Management
- GMP Surveillance and Education
- Organization and Resources
Leadership & Budget ResponsibilitiesProvides guidance and leadership for the department. Contributes to the direction and oversight of the operational aspects of Corden Pharma Colorado by advising the site Operating Committee.
Safety & Environmental ResponsibilitiesEvery individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.
QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION And/or EXPERIENCEBachelor's Degree from college or university; and 10 years of related experience; or equivalent combination of education and experience.
Language SkillsAbility to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.
Mathematical SkillsAbility to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
REASONING ABILITYAbility to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent, and to draw and interpret bar graphs.
CERTIFICATES, LICENSES, REGISTRATIONSNone.
PHYSICAL DEMANDSThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit; work with hands; and talk or hear. The employee is occasionally required to stand; walk; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include ability to adjust focus.
WORK ENVIRONMENTThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, and noise typical of an office environment.
CORE COMPETENCIESThese are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.
- Leadership and deep knowledge of the concepts (above described as responsibilities)
- Governance and decision making regarding regulatory compliance and operational knowledge of API manufacture
- Effective in prioritizing workloads, resolution of issues based on compliance, and scientifically documented risk
- Excellent customer service skills
- Business acumen to drive successful customer experience while meeting business targets from a Quality perspective
- Good written and oral communication skills
- Computer skills with intermediate ability to use Microsoft Office Suite
- Strong planning, implementation, and follow-up skills
- Good facilitation skills and ability to interact with colleagues from all levels of the organization
- High analytical capabilities
Benefits
- 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
- Accident Plan
- Critical Illness Insurance
- Dental Insurance
- Disability Insurance
- Employee Assistance Program
- Flexible Spending Account
- Health Insurance PPO/HSA
- Hospital Indemnity Plan
- ID Theft Protection
- Life Insurance
- Paid Maternity/Paternity Leave
- Tuition Reimbursement
- Wellness Program
- Vacation – Three Weeks 1st Year
- Vision Insurance
Job Summary
JOB TYPE
Full Time
INDUSTRY
Durable Manufacturing
SALARY
$191k-232k (estimate)
POST DATE
05/25/2024
EXPIRATION DATE
07/18/2024
WEBSITE
cordenpharma.com
HEADQUARTERS
CHENOVE, BOURGOGNE-FRANCHE-COMTE
SIZE
500 - 1,000
FOUNDED
2006
CEO
YVES JEAN MICHON
REVENUE
$10M - $50M
INDUSTRY
Durable Manufacturing
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The job skills required for Associate Director, Quality Operations include Leadership, Initiative, Planning, Quality Assurance, Collaboration, Customer Service, etc. Having related job skills and expertise will give you an advantage when applying to be an Associate Director, Quality Operations. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Associate Director, Quality Operations. Select any job title you are interested in and start to search job requirements.
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The following is the career advancement route for Associate Director, Quality Operations positions, which can be used as a reference in future career path planning. As an Associate Director, Quality Operations, it can be promoted into senior positions as a Top Quality Assurance Executive that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Associate Director, Quality Operations. You can explore the career advancement for an Associate Director, Quality Operations below and select your interested title to get hiring information.
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