This position is a full-time on-site role (M-F business hours)

About This Role

The Senior Associate III, Quality Engineering is responsible for oversight of key functional, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) Bio facility. The QE Sr. Associate III will perform all duties in a manner consistent with site and corporate policies, cGMPs, safety, environmental and human resources policies and procedures and be proficient in their understanding of the Biogen Quality Systems and apply that knowledge in coaching and continuous improvement for all Quality Systems cross-functionally. Additionally, this role champions the overall GxP change management process to ensure execution of an effective and compliant program at the Biogen RTP Bio facility. The role will have leadership responsibilities and capabilities to influence, impact, and collaborate with all levels of the organization to achieve meaningful outcomes. The Senior Associate III, Quality Engineering serves as the subject matter expert on the electronic quality system and maintains a thorough understanding of system capabilities to provide support to record owners.

WhatYou'llDo

• Provide quality direction to the business to ensure efficient and effective execution of GxP Change Control processes

• Assist with site changes and apply relevant and necessary actions to ensure appropriate levels of compliance

• Schedule and Chair Change Review Board (CRB) Meetings. Maintains CRB meeting agendas, materials and tracking lists

• Liaise and influence cross functional teams to drive site changes to meet supply reliability via coordination of risk assessments, planning meetings, and partner quality collaboration. Demonstrate agility, collaboration, and leadership to achieve the key quality and supply metric

• Review and approval of facility, utility, equipment, analytical instruments and automation lifecycle documentation including; User Requirements, Specifications, Drawings, Risk Assessments, Test Protocols, Deviations, Reports, Procedures and Periodic Reviews

• Provide cGMP guidance and quality risk management support of manufacturing on the floor issues with equipment or systems, including review and approval of deviations and Corrective/Preventive Actions (CAPAs)

• Serve as the key quality resource for the Bio site participating and providing input and suggestions to support global Change Control system enhancements

• Author, review, and/or approve procedures, as applicable, to ensure appropriate and harmonized processes are in place

• Participate in Regulatory inspections and third party audits as a Subject Matter Expert

• Serve as local contact for site instance of the Global Change Control platform

• Additional job duties as assigned

Required Skills

• Minimum Bachelor's Degree requiredin Life Sciences or other technical discipline

• Minimum 7 years' experience directly related to position responsibilities, working within a quality GMP biotech or biopharma environment

• Specialized knowledge in GxP change management processes and regulatory guidance

• Knowledge of validation and quality systems

• Proven ability to develop innovative/creative solutions for issues of moderate to challenging complexity

• Detail oriented aptitude

• Excellent oral and written communication skills; ability to communicate with all levels of the organization

Preferred Skills

• Supervisory or related leadership experience with decision making

• Experience working in a large molecule biotech environment

• Experience using Veeva

Additional Information

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.

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 onto learn more about our DE&I efforts.

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.