Quality Assurance Senior Specialist - Compliance (Contract) 23271-2

Company: Vertex
Location: Boston
Posted on: February 8, 2025

Job Description:

Job DescriptionThe Sr. Quality Specialist - Compliance is recognized as an expert internally in the principles and application of quality assurance and compliance. The Sr. Quality Specialist will coordinate GMP activities in support of clinical and commercial Drug Product disposition. This position reports to Manager GMP Quality - Cell & Gene.REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIESKey Skills

• Cross-functional collaborator
• Results DriverKey Knowledge/ Skills and Competencies
• Strong leadership skills with the ability to thrive in a high throughput environment
• Collaboration / Teamwork
• Ability to independently lead cross-functional teams and represent the Quality unit
• Communication
• Ability to communicate effectively across all organizational levels
• Critical Thinking / Problem Solving
• Ability to evaluate quality matters and make decisions utilizing a risk-based approach
• Attention to detail
• Expert knowledge of GMP requirements governing oral drug products manufacturing practices
• Proven experience supporting GMP manufacturing either via experience in manufacturing and/or experience providing QA operational support of GMP manufacturingKEY RESPONSIBILITIES:
• Provide quality oversight and support to Vertex Cell and Gene Therapy operations in key areas/activities, including support of manufacturing operations across all phases of development and commercial, support of analytical laboratory, materials management, and facility/engineering groups.
• Lead root cause analysis and product impact assessments for investigations resulting from deviations. Ensure appropriate correction, interim controls, and CAPAs are in place to mitigate risks.
• Liaise with cross-functional teams and support quality partners to ensure GMP manufacturing and testing activities, including disposition timelines, are met.
• Lead/execute continuous improvement activities.
• Provide QA support for change controls, GMP investigations, and CAPAs. Oversee OOS and OOT investigations and ensure appropriate CAP actions are identified.
• Provide project support involving technical transfers, engineering projects, and similar activities.
• Participate in compliance walkthroughs and help drive the closure of any observations as needed.
• Identify risks and communicate gaps for GMP processes/systems.
• Identify risks and communicate any gaps for quality processes optimization for area/equipment release, material disposition, quality systems, etc.
• Participate in continuous improvements of department processes.
• Participate in inspection readiness and support activities.
• Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with business owners to facilitate resolution of quality issues in a timely manner.REQUIRED EDUCATION AND EXPERIENCE:
• Demonstrated success by independently leading cross-functional teams.
• Experience providing QA support and oversight of GMP manufacturing operation including batch release.
• Experience with ATMP drug product development and manufacturing with proficient knowledge in a pharmaceutical setting.
• Knowledge of cell and gene therapy cGMP's and associated CMC regulatory considerations.
• Experience in aseptic processing.
• Experience successfully leading event investigations, Root Cause Analysis, and CAPA.
• Experience with network-based applications such as Oracle, TrackWise.
• Master's degree with 2-3 years of relevant work experience, or Bachelor's degree in a scientific or allied health field with a minimum of 3-5 years of relevant work experience, or relevant comparable background.Pay Range$55-$65/hr
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Keywords: Vertex, Boston , Quality Assurance Senior Specialist - Compliance (Contract) 23271-2, Other , Boston, Massachusetts