Senior Manager, QA Operations (GTM)

Job Description

The Sr Manager, Quality Assurance (QA) Operations for Gene Therapy Manufacturing (GTM) will be a key team member for start-up and operation of Biogen’s newest facility. This leader will build, recruit, develop, and lead the QA Operations function responsible for GTM start-up and routine operations, overseeing batch release and disposition activities for plasmids, cell banks, drug substance, and drug product. This position will report in to the Head of GTM QA&QC and lead Quality efforts on documentation, exception resolution, and metric tracking.

What You’ll Do

· Recruit, coach, and develop team members and their career paths

· Managecompliance overtight activities across multiple QMS subsystems to ensure safety, efficacy, identity, and purity of products in scope of GTM

· Ensure timely resolution of process and testing exceptions and deviations

· Develop and implements Quality documentation management strategy

· Implement strategy for trancing and reporting on GTM Quality Metrics and Site Compliance

· Ensure GTM is inspection-ready and directly support inpection activities

Who You Are

You are a Quality Professtional with proven experience supporting the GMP production of complex biological therapies that will change patients’ lives. You are a passionate people leader who values and drives culture. You are agile and willing to flex to support the needs of a dynamic start-up environment.

Qualifications

Required Skills

· Bachelor’s degree in Chemical/Biological Sciences, engineering, or related field, or equivalent experience

· A minimum of 7 years of experience

· At least 5 years proven leadership of high-performing teams

· Experience in CMC Quality for biological molecules (proteins, mAbs, etc)

· Advanced knowledge of CMC product development, operations, quality systems, and regulatory compliance

· Excellent technical writing, presentation, and oral/written communication skills.

· Ability to lead through complex issues, assess risks, and problem-solve to effectively drive cross-functional decisions

Preferred Skills

· At least 5 years experience in a GMP-regulated environment

· Experience in gene therapy or advance therapy medicinal product (ATMP) CMC Quality



Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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