Quality Assurance Manager, Biologics

Eurofins CDMO Alphora is looking for an exceptional Quality Assurance Manager to support our Biologics team!

Eurofins CDMO Alphora is looking for a Quality Assurance Manager, Biologics who will be accountable to the Director, Quality & Compliance. They will contribute to Eurofins CDMO Alphora Inc.’s compliance with Current Good Manufacturing Practices (cGMP) to ensure the production of safe and efficacious clinical and commercial pharmaceuticals on behalf of our clients and their patients. The QA Manager, Biologics will be responsible for the oversight of GMP activities specific to the Biologics operating unit, including the development and commercialization of pharmaceuticals of biotechnology origin, including monoclonal antibodies (mAbs) and other mammalian-based therapeutic proteins, and antibody drug conjugate (ADC) candidates. The Biologics GMP operations will include a clinical GMP clean room suite, GMP analytical/QC laboratory, and large scale GMP facility with Sterile Fill line.

KEY DUTIES AND RESPONSIBILITIES:

1. Responsible for the general oversight of all quality and GMP activities within the Biologics operating unit related to facility, operations and analytical.

QMS Development

• Participate in the development and establishment of GMP quality management systems specific to the development, manufacture, and testing of Biologics. Biologic specific requirements will be incorporated into existing QMS for clinical and commercial API and Drug product.
• Participate in the continuous improvement of quality systems, policies and procedures based on quality system data/KPIs and Regulations.
• Write, review, and approve Standard Operating Procedures (SOPs).
• Contribute to preparation and approval of various quality documents as a Quality SME.

Quality Oversight

• Provide production support including equipment and line clearances.
• Perform oversight of batch manufacturing and final product packaging operations.
• Review/assess change controls.
• Review/develop system qualifications for production and analytical equipment.
• Participate/lead quality oversight initiatives as assigned.

Deviations and Investigations

• Responsible for developing investigation plans, leading investigations, root cause analysis, risk and impact assessments, determination of CAPA, and final report issuance.
• Provide support, guidance and training to QA Associates and other departments.
• Collaborate with clients as required.

Master Record Approval

• Responsible for the review and approval of GMP documentation – Master batch records, Specifications, Test Methods, Sampling/Labelling/Analysis Forms, etc.

Batch Review and Release

• Review executed batch records and production cleaning study reports for accuracy, completeness and compliance to established CGMP or other regulatory standards.
• Support assignment of batch disposition to Product’s manufactured/tested at Alphora – ensure all testing and manufacturing records have been reviewed for compliance to GMP and SOPs prior to assignment of disposition.
• Compile batch release documentation packages and related certification statements.

Testing Data Review and Release

• Review analytical data and protocols for standard qualification, stability, method qualification and method validation protocols for accuracy, completeness and compliance.
• Review quality control lab data for raw materials, in-process controls, intermediates and APIs for accuracy, completeness and compliance to CGMP or other applicable regulatory standards.

Audit Support

• Assist in preparation/coordination of customer and regulatory agency audits.
• Support and/or direct internal company audits.

Regulatory Support

• Assist in development of the Chemistry, Manufacturing and Controls portion of the client submissions in support of IND’s, NDA’s, and BLA’s as assigned.

Contribute to QA department meetings by providing project status reports as well as identifying and leading continuous improvement activities.

Participate in opportunities to develop knowledge of CGMP and business operations.

Represent Alphora QA on client projects, as assigned.

Qualifications

The ideal candidate will:

• 5-10 years of pharmaceutical quality assurance/control in GMP setting.
• Experience with development, manufacture and testing of pharmaceuticals.
• Experience with Biologic pharmaceuticals, in particular mAbs and ADCs is an asset.
• Sterile fill/aseptic processing experience preferred.
• Minimum education: B.Sc. – Biochemistry, Microbiology or related discipline.

COMPANY DESCRIPTION

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labeling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 58,000 staff across a network of more than 1,000 independent companies in over 54 countries and operating more than 900 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.

In 2023, Eurofins generated total revenues of EUR 6.515 billion, and has been among the best performing stocks in Europe over the past 20 years.

Additional information

At Eurofins we offer excellent full-time benefits including health & dental coverage, life and disability insurance, RRSP with 3% company match, paid holidays, paid time off.

As a Eurofins employee, you will become part of a company that has received international recognition as a great place to work. To learn more about Eurofins, please explore our website at www.eurofins.ca.

We thank all applicants within commuting distance of GTA, Ontario for showing an interest in this position. Only those selected for an interview will be contacted.