Quality Control Manager (External Operations)

Responsibilities

• Manage cGMP testing (in-process, release, stability) at CDMOs and contract laboratories.
• Manage day-to-day Quality Control Operations at external partners.
• Manage laboratory investigations, deviations, change controls, CAPAs and risk assessments.
• Manage the review and approval of Quality Control data and CoA/CoTs.
• Manage material specifications for excipients, drug substances and drug products.
• Manage the shipment of quality control samples from/to CDMOs and contract laboratories.
• Absorb and assist in coordination, oversight, and review of method validations at CDMOs and contract laboratories.
• Carefully coordinate stability sample storage and testing per approved protocols.

Requirements

• B.S. or M.S. degree in chemistry, biochemistry, biological sciences, pharmaceutical sciences, or related field.
• 5+ years of relevant experience in the pharmaceutical or biotechnology industry.
• 3+ years of demonstrated quality experience in a cGMP-regulated QC laboratory.

Qualifications

• Technical experience with QC analytical techniques, such as HPLC, GC, CE, UV-VIS, ELISA, and cell-based potency assays.
• Ability to communicate across various cross-functional teams.
• Experience authoring, reviewing and approving documents in Electronic Document Management Systems (Veeva).
• Knowledge and understanding of ICH guidelines, FDA/EMA regulations, and cGMP documentation practices.
• Experience with external vendor management (client or client facing function).
• Strong self-management and organizational skills, ability to prioritize, critical decision-making skills, and problem solving.
• Self-motivation and leading the way for ensuring a fair and equitable work environment.
• Thorough attention to detail, with the ability to critically analyze ideas, data, and reports.
• Strong oral and written communication and interpersonal skills.