The Quality Technical Services & Compliance (QTSC) Senior Associate II is responsible for understanding quality systems, contributing to oversight of quality systems, and for the oversight of key functional and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. The Senior Associate II 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 System cross-functionally.
What You'll Do
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).
Review and approval of changes affecting validated analytical instruments, manufacturing processes, equipment, facility, utility, automation systems, materials/components, and business processes associated with IT GMP computerized systems.
Support the site changeover program by providing oversight of multi-product equipment inspection and release including the review of changeover documentation, sampling, elastomer replacement, carry-over calculations, engineering configuration, summary reports and equipment release.
Support site capital projects by providing GMP guidance, risk management input and quality oversight during shut down planning, release and other major equipment/facility improvements.
Review and approve GMP Preventive/Corrective maintenance work as applicable.
Lead investigations and CAPAs including driving Continuous Improvement initiatives.
Proactively identify and resolve both technical and compliance issues/gaps.
Develop and implement aspects of various Quality Systems/System Improvements.
Develop and deliver training on basic GxP quality systems. Provide mentorship and training within and across functions.
Who you Are
You are a motivated QA expert with sound Drug Manufacturing/Engineering experience/knowledge who is capable of being flexible with changing priorities. You are detailed oriented, a strong critical thinker and can work across multiple levels of the organization. You are truly a team player, knowing that when the team succeeds, we all succeed. You have a high level of personal accountability and are able to constructively hold peers and stakeholders accountable to their commitments.
Qualifications
Bachelor's Degree, preferably in Engineering, Life Science or Technical discipline.
6 years of relevant industry experience.
Thorough knowledge of FDA/EMA regulations including Current Good Manufacturing Practices (cGMPs) and International Council for Harmonization (ICH) guidelines.
Thorough Knowledge of Quality Engineering Systems (Facilities, Utilities, Maintenance, Engineering, Validation, and Automation).
Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to effectively communicate and collaborate with technical and senior management staff.
Experience in managing multiple, competing priorities in a fast-paced environment and dealing with ambiguity.
Demonstrated troubleshooting and strong problem-solving skills and the ability to develop innovative/creative solutions to issues of moderate or high complexity.
Preferred Skills
Thorough knowledge and/or previous experience with cGMP Drug Substance or Drug Product Manufacturing environments.
Ability to evaluate compliance issues and interact with regulatory inspectors.
Experience in QA oversight of manufacturing, analytical and engineering activities.
Experience in investigations, change controls, and CAPAs processes system knowledge.
General knowledge of Project Management competencies obtained through relevant PM training or experience.
General knowledge of industry best practices including ISPE Baseline Guide 5, GAMP5 and ASTM E-2500.
Experience in Engineering and/or Validation (Equipment, Cleaning, Computerized Systems) preferred.
Additional Information
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
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 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.
