Quality Assurance Manager

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Responsibilities:

* 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 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 the company's regulations of applicable authorities.

* 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

Skills:

* 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 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.

Education:

* The candidate for this position should hold a BS degree in Chemistry or a related field, or equivalent combination of education and experience.

* 2-5 year's experience in an FDA regulated biotechnology, pharmaceutical or medical device company.

* Experience in good documentation practices and the ability to review technical documents

Required Skills:

*

BATCH RECORDS

*

CGMP

*

DOCUMENTATION

Additional Skills:

*

FILINGS

*

GMP

*

OUTSOURCED MANUFACTURING

*

TESTING

*

TRANSMISSIONS

*

OPERATIONS

*

PACKAGING

*

PRODUCT DEVELOPMENT

*

QUALITY ASSURANCE

*

REGULATORY AFFAIRS

*

SUPPLY CHAIN

*

TRAINING

*

AUDIT

*

BIOTECHNOLOGY