Quality Assurance Senior Specialist - Compliance (Contract) - Boston - ref. v46296715

This position reports to Manager GMP Quality - Cell & Gene.

KEY RESPONSIBILITIES:

• As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to Vertex Cell and Gene Therapy operations in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of analytical laboratory, materials management, and facility/engineering groups.
• Leads from a Quality perspective root cause analysis and product impact assessments for investigations resulting from deviations. Assure appropriate correction, interim controls and CAPAs are in place to mitigate risks
• Liaises with cross-functional teams and support quality partners to ensure GMP manufacturing and testing activities, including disposition timelines are met.
• Leads/executes continuous improvement activities.
• Provide QA support of change controls, GMP investigations and CAPAs. OOS and OOT investigations and ensuring appropriate CAP actions are identified.
• Provides project support involving technical transfers, engineering projects and similar activities
• Participate in compliance walkthroughs and help drive the closure of any observations as needed
• Responsible for identifying risks and communicating gaps for GMP process/systems
• Responsible for identifying risks and communicating 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
• Participate in process improvement initiatives (as necessary).
• Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely manner

• 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 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 manufacturing

Requirements

EDUCATION AND EXPERIENCE:

• Master’s degree with 2-3 years of relevant work experience OR
• Bachelor’s degree in a scientific or allied health field with minimum 3-5 years of relevant work experience, or relevant comparable background.
• 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 of the following in a pharmaceutical setting
• Cell and gene therapy cGMP’s and associated CMC regulatory considerations
• Aseptic processing
• Experience successfully leading event investigations, Root Cause Analysis and CAPA
• Experience with network-based applications such as Oracle, TrackWise