Assc. Director/Director, Quality Control/Analytical – NC Pharma/Top $$
Our client, a high profile specialty pharmaceutical firm in the RTP area, is actively recruiting for a skilled and knowledgeable candidate to drive all Analytical and Quality Control efforts. Company is open to both Director and Assc Director level candidates. It is a critical role and Company will pay excellent wage to attract and retain the right candidate.
This company is experiencing unprecedented growth. In addition to several acquired commercial products it boasts a rich pipeline of products in development, including one that is near launch. This D/AD will be responsible for developing and implementing the Quality Control and Analytical processes needed to meet the needs of the future. Seek candidate whose exceptional scientific credentials are complemented by broad regulatory knowledge and keen operational savvy.
Key Things to Note:
- This D/AD will be the company’s Subject Matter Expert (SME) on QC and Analytical activities. The position will begin as a department of one – with the expectation of expansion in the future.
- Company relies heavily on CMOs and contract labs for production and testing functions. Right candidate will be accustomed to overseeing the work performed by 3rd party vendors.
- This is an emerging business in which policy, practices and procedures are still being refined. Seek candidate with the ability to develop and enhance analytical methods, streamline QC activities, and build SOPs.
- Role will involve extensive Regulatory and SOP Writing. Seek scientist with strong writing/editing skills.
This AD/Director will be responsible for developing and managing all aspects of the Quality Control program including ensuring the appropriate level of quality control for commercial and development activities. This position will implement, design, develop, and manage cGMP training, document control, change control and all other aspects of the Quality Management System and will support the VP, Quality in providing input on strategic direction for the QA program and best practices for quality initiatives.
Selected duties will include:
- Oversee the development and validation of analytical methods for small molecules for starting materials, intermediates, and active pharmaceutical ingredients:
- Develop and/or assess the suitability of the analytical methods for intended purpose
- Author or approve analytical methods
- Author or approve method validation protocols and reports
- Author and/or review analytical specifications
- Oversee Raw Material, Finished Good, Microbiology and stability programs related to company products
- Review all stability data and investigations related to the drug substance and/or drug products for various techniques. (HPLC, Dissolution etc.)
- Implement quality control processes, specifications, validation reports; both externally and internally to support company products.
- Oversee and manage CRO/CMO/Contract Labs engaged in AD and QC activities.
- Provide technical review of analytical data integrity and laboratory documentation, method development reports and method validation protocols/reports.
- Maintain stability project plans and their associated timelines, including readiness of sampling plans and coordinate with technical operations that sample availability for stability studies.
- Responsible for Out of Specifications, Out of Trend, and Laboratory investigations Design, development, implementation, and oversight of cGXP Quality Control Systems in the pharmaceutical industry. (21 CFR 210, 211, 600, 820,)
- Author, update, and revise CMC regulatory filing sections to support regulatory filings. Address CMC comments regulatory responses.
- Support third-party audits and regulatory inspections, including preparing SMEs, representing QC with inspection teams, and managing closure of commitments related to the analytical testing as required in response to observations and other findings.
- Perform deviation investigations and CAPA implementation in support of CMC QC projects and improvement.
- Prepare and revise technical documents. (Laboratory Protocols, change controls, laboratory investigations, CAPAs, SOPs, etc.)
- Provide Quality Control input to strategic goals in form of schedules, plans, and budgets.
Targeted candidate will offer a Scientific Degree (advanced degree expected) and 10+ years of directly related Quality Control/Analytical experience including substantial knowledge of international GxP regulations and guidelines, industry practices, and experience implementing quality control programs in a regulated environment.
Other priorities include:
- Extensive knowledge of the analytical method development and validation
- Demonstrated ability to lead projects conducted at third party manufacturers and laboratories
- Experience in authoring technical reports and CMC sections for regulatory filings
- Ability to manage multiple projects, set priorities, and work in a fast-pace environment
- Longevity, impact and growth in previous roles
Finally and critically we seek a candidate who will thrive in a highly dynamic setting. Someone who can switch gears readily, stay focused despite disruption and who can bring enhancements and ideas. The future is very bright, but the present is ever-changing. Seek a contributor who enjoys the challenge and stays focused on the mission.
Please forward Word resume for prompt consideration. Local candidates only.