Global Head of Biologics Product Quality

Regulatory Jobs; Cambridge (MA); Hybride; USD 184 000 - 253 000; Plein temps

Avantages offerts par ce poste

Medical, Dental, Vision

Wellness programs

Paid vacation and holidays

401(k) with match

Employee stock purchase plan

Tuition reimbursement

Résumé du poste

Biogen is seeking a Head of Global Product Quality for Biologics to lead a dynamic PDQ team. This role spans strategic, tactical, and operational governance to ensure GMP compliance across the biologics portfolio.

You will coordinate with CMC Asset Team and Quality orgs to drive innovation and best practices. The position is hybrid, based at Biogen facilities in RTP, NC or Cambridge, MA, with responsibilities including regulatory strategy, staff development, and cross-functional collaboration to

Qualifications

• Bachelor’s degree or higher in a scientific field.
• 12+ years in pharma/biologics with product quality focus.
• 7+ years in quality within biopharmaceutical production.
• 5+ years in people and project management.
• Strong knowledge of GMP, GCP, GDP, ICH and global regs.
• Experience in international matrix environment.
• Excellent written and verbal communication.
• Ability to influence stakeholders and negotiate.

Responsabilités

• Lead asset strategy and compliance best practices across products within a modality.
• Review major regulatory submissions and help set regulatory strategic plans.
• Develop and cross-train staff for 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 trends.
• Ensure timely completion of Annual Product Review and trend monitoring.
• Support internal/external audits of CMOs and audits for devices.

Description du poste

Biogen is seeking a Head of Global Product Quality for Biologics to lead a dynamic PDQ team. This role spans strategic, tactical, and operational governance to ensure GMP compliance across the biologics portfolio.

You will coordinate with CMC Asset Team and Quality orgs to drive innovation and best practices. The position is hybrid, based at Biogen facilities in RTP, NC or Cambridge, MA, with responsibilities including regulatory strategy, staff development, and cross-functional collaboration to