Supervisor, Manufacturing Compliance
Company: AGC Biologics
Posted on: May 16, 2022
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
The Supervisor, Manufacturing Compliance oversees day-to-day
responsibilities of the compliance team, including people
management and planning, ensuring compliance with established
processes and standards.
- Ensure compliance with company quality systems, safety
procedures, and other company policies.
- Plan daily activities, priorities and workflow for
Manufacturing as it relates to deviation and CAPA management.
- Provide training, mentorship, and coaching to staff within the
- Represent MFG Compliance at internal and external meetings
(e.g. deviation triage, lot disposition, client and supplier
- Work closely with Manufacturing operations and Quality
Assurance to drive deviations to timely closure.
- Provide direction to employees according to established
policies and management guidance.
- Prepare and deliver routine reports and communications to site
regarding deviation status.
- Participate in and lead improvement projects for Manufacturing
operations and manufacturing compliance.
Knowledge, Skills & Abilities
- Ability to understand and apply GMP regulations as they relate
to manufacturing and quality management systems
- Demonstrated ability to apply understanding of how the team
relates to other related areas to improve efficiency of own
- Solid understanding of the processes, procedures and systems to
produce high-quality work on standard problems within the
- Ability to recognize needed performance improvement and convey
feedback in a positive, constructive manner
- Ability to work across teams effectively
- Strong technical writing and communication skills
- Strong computer literacy required
- BS in scientific discipline such as Biochemistry, Chemistry,
Biology or related discipline required
- 5+ years of industry experience required
- Previous supervisor or manager experience preferred
- Experience conducting GMP investigations within
clinical/commercial manufacturing environment required
- Experience using quality management systems software (e.g.
MasterControl, TrackWise) required
- Equivalent education and experience may substitute for stated
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
Keywords: AGC Biologics, Seattle , Supervisor, Manufacturing Compliance, Other , Seattle, Washington
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