Head of Global Product Quality- Biologics
About The Position
As the Head of Global Product Quality for Biologics, you will lead a dynamic team responsible for overseeing all product quality aspects within Biogen’s biologics portfolio. Your role will encompass strategic, tactical, and operational management within the Product Development Quality (PDQ) department, ensuring that all quality-related aspects align with Biogen’s policies and GMP guidelines. You will facilitate the execution of activities between business partners, the CMC Asset Team, and the Quality organization, while empowering your team to drive innovation and best practices. Your leadership will ensure alignment across the portfolio, leveraging adjacent experience to lead teams on existing and new products and technologies. This pivotal position not only guarantees quality compliance but also develops the capabilities of your direct reports and broader organization in team management and quality issues. Your contribution is vital to maintaining our commitment to product excellence and innovation. This is a hybrid role based either at our office in Research Triangle Park, NC or Cambridge, MA.
Requirements
- Bachelor’s degree and at least 12 years of experience in the pharmaceutical industry, with biological product development and/or production.
- At least 7 years of experience in Quality associated with biopharmaceutical/pharmaceutical production.
- Minimum of 5 years of experience in people management and project management.
- Extensive knowledge in GMPs, GCP, GDP, ICH, and international regulations.
- Experience in an international matrix environment.
- Technical expertise in manufacturing, testing, or technical development.
- Strong written and verbal communication skills.
- Ability to influence partners and stakeholders with strong negotiation skills.
Nice To Haves
- Inspiring leader with a passion for quality and excellence in biologics.
- Ability to empower and develop your team sets you apart as a mentor and coach.
- Thrive in collaborative environments, seamlessly integrating strategic vision with operational execution.
- Innovative mindset drives you to tackle complex challenges, finding solutions that enhance product quality and compliance.
- Adept at navigating cross-organizational relationships, influencing stakeholders, and fostering a culture of continuous improvement.
Responsibilities
- Lead asset strategy and compliance best practices across products within a modality.
- Review major regulatory submissions and help set up regulatory strategic plans.
- Develop and cross-train staff for maximum flexibility and growth.
- Execute specification strategy for regulatory submissions and address agency concerns.
- Collaborate with cross-functional teams to support product specifications and shelf-life strategy.
- Serve as the Specification Review Board Chair and ensure cross-functional vetting of specifications.
- Represent Biogen at external forums to stay abreast of emerging expectations and trends.
- Ensure timely completion of Annual Product Review/Product Quality Review and trend monitoring.
- Support internal audits, certifications, and external audits of CMOs.
- Support combination product and device implementations in asset strategy.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
