3 Senior Manager, Quality Compliance Jobs in Bothell, WA
SORT BY
A
B
B
Senior Manager, Quality Compliance
$126k-158k (estimate)
Full Time | Durable Manufacturing
1 Week Ago
AGC Biologics is Hiring a Senior Manager, Quality Compliance Near Bothell, WA
Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.
SummaryThe Sr. Manager, Quality Compliance is responsible for overseeing and directing activities for supporting compliance with regulatory, corporate, site and client expectations. This includes developing, managing and enhancing systems to oversee and maintain compliance; hosting Regulatory Inspections, Corporate Quality Audits, Client Audits; supporting Supplier Audits; Managing and executing the Site Internal Audit program. In addition, this position ensures compliance with Regulatory Agency and State licensing requirements and maintains relevant documentation and licenses.
Principal Responsibilities
Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
SummaryThe Sr. Manager, Quality Compliance is responsible for overseeing and directing activities for supporting compliance with regulatory, corporate, site and client expectations. This includes developing, managing and enhancing systems to oversee and maintain compliance; hosting Regulatory Inspections, Corporate Quality Audits, Client Audits; supporting Supplier Audits; Managing and executing the Site Internal Audit program. In addition, this position ensures compliance with Regulatory Agency and State licensing requirements and maintains relevant documentation and licenses.
Principal Responsibilities
- Develops and maintains systems and processes for management of regulatory inspections and client audits
- Develops and maintains systems for maintaining inspection readiness including processes, preparation and training
- Coordinates and schedules inspection readiness activities
- Monitors the status and reports on Inspection readiness and site compliance risks
- Generates timely responses to inspection observations, client audit observations in conjunction with functional area leads. Provides LT and Site Leadership approved responses to the authorities and clients respectively
- Generates and obtains approval for internal audit schedule. Executes internal audit program.
- Ensure GMP compliance issues are addressed proactively, and support quality of new processes and products
- Supports Supplier Quality Audits and other audit activities (Global audits) as requested
- Ensures regulatory activities/communications, licensing, etc. are maintained
- Maintains updated Drug Master File
- Develops and maintains site understanding of regulatory concerns and trends
- Establishes operational objectives and work plans and delegates assignments to subordinates. Senior management reviews objectives to determine success of operation. Involved in developing, modifying and executing company policies that affect immediate operations and may have company-wide effect.
- Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
- Erroneous decisions will result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities.
- Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers. Requires the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.
- Ability to understand and apply GMP regulations as they relate to manufacturing, raw materials, testing and facility operations
- Demonstrated ability to effectively manage multiple tasks utilizing organization and prioritization skills, self-motivated
- 4-6 years of experience managing, leading and/or serving in audit role with regulatory agencies, clients and internal audit programs
- Understanding of US and EU regulations and current regulatory trends
- Strong interpersonal, written and oral communication skills
- Strong problem solving skills
- BS in Physical Sciences, Life Sciences or Engineering: advanced degree is preferred
- 10 year’s relevant experience in biotechnology and GMP environment
- Experience with QA and GMP compliance in clinical and commercial drug substance manufacturing
Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Durable Manufacturing
SALARY
$126k-158k (estimate)
POST DATE
06/22/2024
EXPIRATION DATE
07/13/2024
WEBSITE
agcbio.com
HEADQUARTERS
BOULDER, CO
SIZE
200 - 500
FOUNDED
2018
TYPE
Private
CEO
PATRICIO MASSERA
REVENUE
<$5M
INDUSTRY
Durable Manufacturing
Related Companies
About AGC Biologics
AGC Biologics is a contract development and manufacturing organization that engages in the development and manufacture of biopharmaceuticals.
Show more
Similar Jobs
Popular Articles
Top 10 Things to Avoid Putting on a Job Application
Read Article
How to Describe Your Education in a Resume
Read Article
How to Write a Memorable Cover Letter in 5 Ways
Read Article
4 Personal Finance Tips to Make During Job Transition
Read Article
4 Best Camera Setups for Interview
Read Article
Keeping a Job Search Journal: 9 Types of Journaling You Can Do
Read Article
