Head of Global Product Quality- Biologics

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

Avantages offerts par ce poste

Medical, Dental, Vision, & Life insur.

Fitness & Wellness programs

Paid time off & holidays

Tuition reimbursement

Résumé du poste

Biogen is seeking a Head of Global Product Quality for Biologics to lead a dynamic team responsible for all product quality aspects within Biogen’s biologics portfolio. The role encompasses strategic, tactical, and operational management within the Product Development Quality (PDQ) department, aligning with GMP guidelines and Biogen policies.

Hybrid role at RTP, NC or Cambridge, MA. The position requires extensive GMP/GxP expertise, global regulatory experience, and a proven track record in

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

Leadership

Quality management

GMP knowledge

Regulatory knowledge

Cross-functional collaboration

Communication skills

Stakeholder influence

Formation

Bachelor’s degree in Pharmaceutical Science or related field

Description du poste

About This Role

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.

About This Role

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.

What You’ll Do

• 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.

Who You Are

You are an inspiring leader with a passion for quality and excellence in biologics. Your ability to empower and develop your team sets you apart as a mentor and coach. You thrive in collaborative environments, seamlessly integrating strategic vision with operational execution. Your innovative mindset drives you to tackle complex challenges, finding solutions that enhance product quality and compliance. You are adept at navigating cross-organizational relationships, influencing stakeholders, and fostering a culture of continuous improvement.

Required Skills

• 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.

Job Level: Management

Additional Information

The base compensation range for this role is: $184,000.00-$253,000.00

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

Benefits

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:

• 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

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.