This individual will work in the GMP Clinical QA sub-group of the Product Lifecycle Quality group of Shire. This unit has Quality Assurance oversight for contract manufacturing operations, supply chain operations and supplier quality functions performed on behalf of Shire. This individual will be responsible for the successful, timely completion of goals and objectives of several Clinical Products/programs, which will strengthen the Shire Quality organization. This position will have no direct reports.
The individual may be responsible for, but is not limited to:
35%: Batch documentation review and release activities per Shire quality systems:
- to provide QA support for the manufacturing, packaging and control of clinical trial materials to ensure compliance with GMP and regulatory requirements
- to review and approve Master Batch Records and Packaging Labels
- actively participate in project meetings as required
- to be knowledgeable about the products supplied for clinical trials
- Ensure that all required batch documentation is obtained from contractor manufacturer/suppliers to enable the release of product.
30%: Review and approve analytical test methods protocols, Master Batch records, executed batch records, reports, specifications, method qualifications/validations, and stability studies reports as they pertain to Clinical Trial Materials.
- Review regulatory submissions
- Drafting & coordinating Quality Agreements
- review specifications
- Documentation control
15%: Writing, reviewing, and leading deviation investigations , change controls, CAPA, nonconformance, OOS, etc.
5%: To effectively liaise with contractor manufacturers/suppliers regarding technical information and queries.
Ensure clinical complaints, deviations and OOS are adequately investigated and documented.
5%: Drafting product complaint reports and supporting recall efforts
Supporting returns & destructions\
5%: Supporting Technology Transfers of IMPs
5%: Supporting the external auditing program, by leading or participating in external audits.
Building and maintaining strong working relationships with Clinical CMOs
Education and Experience Requirements
- Minimum of a Bachelor’s degree in chemistry, biology, pharmacy or a related discipline
- Experience supporting the external manufacturing of drugs, biologics, or devices.
- Thorough understanding of quality systems and cGMPs.
- Interpersonal skills and professional skills to interact with external contract manufacturers/supplier/test labs, representing Shire.
- Must be flexible and comfortable with ambiguity in a “start-up” environment
- Minimum of 7 years experience working in Quality Assurance role or in a QA environment in the pharmaceutical industry (in a clinical manufacturing/packaging environment preferred)
- Must be able to prioritize and multitask in a stressful environment.
- Must be able to travel up to 10% (domestic and international)
- Must be able to read, understand, speak and write legibly in English
- Quality experience in parenteral biotech manufacturing (aseptic or sterile processing)
- Experience working with a Qualified Person or Responsible Person
- High level of professional competence. Preferably demonstrated by objective certification (e.g. Certified Quality Auditor or Engineer).
- Experience conducting audits
Other Job Requirements
- Ability to work during routine business hours but be flexible to cover US and Europe business hours
- Ability to travel approx. 10%
Location/Region: Lexington, MA