Quality Assurance Senior Specialist - Compliance (Contract)

The 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.

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
  
  
  

Key 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 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