Job Description
General / Position Summary
The Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance.
The Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product disposition. This position reports to Manager GMP Quality - Cell & Gene
The quality role will closely partner with operational stakeholders and participate in associated governance for the successful planning and execution of operational quality.
The successful candidate will be a key member of the Vertex Cell & Genetic Therapy Quality Team and the Virtual Product Team.
Key Duties & 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.
Responsible for batch disposition activities. Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
Responsible for approval of COAs and product labelling.
Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment.
Review and approval of manufacturing documents.
Responsible for GMP release of incoming material and components.
Supports drafting and revising Quality Agreements between CMOs / Suppliers and Vertex, as needed.
Provide QA support of change controls, GMP investigations and CAPAs. OOS and OOT investigations and ensuring appropriate CAP actions are identified.
Participate in compliance walkthroughs and help drive the closure of any observations.
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.
Required Education Level
Bachelor's degree in a biotech / Lifesciences field.
Preferred Master's degree or relevant comparable background.
Required 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.
Required Knowledge / Skills
In-depth global regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and / or Biologics.
Experience in product life cycle from discovery to commercials product development
Broad understanding of regulatory environment (US and EU cGMP regulations / guidance including quality systems, compliance, and strategy.
Broad technical knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies / Biologics processing, fill / finish, and testing.
Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
Excellent communication skills and a proven track record Influencing / building / promoting a culture of Quality and Excellence.
Ability to apply risk management principles to decision making and operational priorities.
Critical Thinking and Problem-Solving skills
Strong leadership and an innate ability to collaborate and build relationships.
On-Site Roles
On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
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