Previous Job
Previous
Manager, Quality Assurance
Ref No.: 17-15496
Location: Marlborough, Massachusetts
The Manager of Quality Assurance oversees GMP compliance of manufacturing, testing, packaging
and release activities of Contract Manufacturing Organizations (CMO's). The Manager will assure
Sunovion, its affiliates and/or contractors associated with the manufacture, packaging, testing and
distribution of drug substances, drug product components and drug products used for investigational
clinical trials and/or commercial phases comply with GMP and have the relevant Quality Systems in
place to comply with standards established by Sunovion as well as regulations of applicable
authorities.
Essential Function
• Conduct product release activities for drug substance and drug product for commercial products, including review and approval of
executed batch records. These activities must be conducted in a timely manner to
ensure continued product supply while ensuring Quality and Safety of the product.
• Effectively work as part of an
internal multidisciplinary team to conduct, review and approve manufacturing, and packaging operations.
• Responsible for compliance to regulatory filings and therefore must have experience in a
Quality Assurance function for marketed pharmaceutical products. The individual must be
able to prioritize activities associated with timelines.
• Support Annual Product Reviews by supplying appropriate metrics to APR reports.
Evaluating manufacturing, packaging investigations and CAPAs

The candidate must be able to manage tasks of varying complexity. The candidate should be
knowledgeable in cGMP requirements for drug product development through marketed product.
Knowledge of drug substance, drug product and solid dosage manufacturing principles, equipment
and processes is preferred. The candidate will interact with internal and external contacts at a
variety of levels. These will include personnel from Commercial Quality Operations, Supply Chain
Operations, Technical Regulatory Affairs, external Quality Assurance facilities, and drug product
development.
Other requirements (licenses, certifications, specialized training, and physical or mental abilities
required):
Responsible for communicating with quality, documentation and production departments at domestic
and international contract manufacturers, Middle Management and peer level personnel within
Sunovion Quality Assurance, Quality Operations, Supply Chain Operations and Quality Compliance
and Audit.
Some travel is required. Travel to CMOs may be required for Business Review Meetings, Quarterly
Review Meetings and on an "as needed” basis.