What are the responsibilities and job description for the Audit Compliance Lead position at CORDEN PHARMA BOULDER INC?
Job Description
Job Description
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.
Corden Pharma 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 five technology platforms : Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; 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.
SUMMARY
Serve as primary lead for scheduling, organizing, and executing audits and inspections at the Corden Colorado site. Partners with Quality and Site Leadership to drive inspection readiness continuous improvement. Develop and enhance both the internal and external Audit / Inspection Program. This is a fully onsite role.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Maintain a deep understanding of regulatory requirements
- Host audits and organize a robust internal inspection team
- Lead client and regulatory inspections
- Responsible for maintaining and communicating client and regulatory audit schedule
- Responsible for internal and external communication regarding audit activities, including scheduling audit responses
- Assist clients in responding to regulatory inquiries and submissions
- Maintain and enhance the Internal Audit Program
- Organize and lead a cross-functional team when responding to any client or agency observations
- Maintain the site risk register
- Identify opportunities for improvement and potential root causes. Work with internal leadership to prioritize activities
- Lead reporting of audit outcomes and CAPAs to internal and external management / leadership
- Perform audit training to a cross-functional team
- May support deviations and own CAPAs
LEADERSHIP & BUDGET RESPONSIBILITIES
No responsibilities for direct management of people but will be required to lead cross-functional teams in ensuring audit / inspection readiness.
SAFETY & ENVIRONMENTAL RESPONSIBILITIES
Every individual is personally responsible for the safety and environmental aspects of their 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.
QUALITY RESPONSIBILITIES
Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPC’s Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company.
cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.
QUALIFICATIONS
To perform this job successfully, an individual must have a strong quality and regulatory knowledge. This individual must have direct experience hosting and supporting regulatory inspections including FDA, EMA, and other agencies.
EDUCATION and / or EXPERIENCE
Bachelor's Degree (BA) from a four-year college or university or an advanced degree. Eight years in a Pharmaceutical setting with experience hosting and participating in regulatory and client audits.
LANGUAGE SKILLS
Ability to read and interpret documents such as regulatory requirements, safety rules, operating and maintenance instructions, and procedure manuals. Ability to write detailed procedures and responses concerning audits and inspection topics.
MATHEMATICAL SKILLS
Ability to calculate figures and amounts such as proportions, percentages, area, and volume. Ability to apply concepts of basic algebra.
REASONING ABILITY
Ability to solve problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
CERTIFICATES, LICENSES, REGISTRATIONS
None.
PHYSICAL DEMANDS
The 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 work with hands and talk or hear. The employee frequently is required to stand, walk, and sit. The employee will be required to walk up and down multiple stairs while leading tours and conducting regular walkthroughs related to audit compliance.
WORK ENVIRONMENT
The 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 fumes or airborne particles, low levels of toxic or caustic chemicals, and outside weather conditions. The noise level in the work environment is usually moderate.
CORE COMPETENCIES
These 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.
SALARY
Actual pay will be based on your skills and experience.
BENEFITS
This post will expire on 3 / 22 / 2025
