Executive Director, CMC Quality Assurance
Our client is a biotechnology company. They have asked us to assist them in a search for an Executive Director, CMC Quality Assurance
Reporting to the Vice President, Quality this position will be responsible for the oversight and execution, from a quality perspective, of chemistry, manufacturing and control (CMC) related activities for early development through all stages of clinical development to commercialization. Key accountabilities include contribution to development, implementation and maintenance of the company’s quality assurance program to ensure GMP compliance of internal/external manufacturing, packaging, distribution and quality controls.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Ensures that all drug substances and drug products are manufactured in compliance with cGMP and consistent with applicable regulatory filings.
- Designs, develops, and leads efforts for QA oversight of the manufacture and disposition of clinical and commercial product materials, DS, DP and Finished Goods internally and at CMOs in partnership with manufacturing, MSAT, Product Development, Supply Chain and other functions.
- Oversees qualification, quality agreements, performance tracking, and reviews of internal/external manufacturing, suppliers and laboratories.
- Manages quality investigations to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions.
- Provides Quality Assurance review of documents in support of regulatory submissions (i.e. CMC sections for INDs and BLAs, to FDA and other regulatory authorities (as applicable) for investigational products, licensing applications and periodic updates. Provides input regulatory responses to regulatory questions during the review period and product lifecycle.
- Works with GxP Quality Management Systems (QMS) to develop internal audit program (self-audit) and provides directors to the external audit schedule and follow up to any finding and ensure any gaps are corrected and sustained.
- Prepares for FDA preapproval onsite inspections and represent GMP QA during inspections.
- Identifies potential QA risks to the strategic/operational plans and proposes options to mitigate risks and proposes quality improvements to Quality Systems to maintain compliance and improve efficiency as part of continuous improvement initiatives.
- Oversees the generation, reviews and/or approvals of internal and external documents used in GMP activities such as, but not limited to, master batch records, manufacturing batch records, stability reports, stability protocols, specifications, deviations, etc.)
- With support from GxP QMS, leads periodic quality management and product quality reviews.
- Designs, develops, and/or reviews CMC QA standards and procedures (i.e., policy documents and SOPs).
- A Bachelor's degree in life science or engineering discipline or comparable experience is required.
- Must have 12+ years of biopharmaceutical manufacturing (internal/external) and quality operations in a leadership or managerial role including experience in clinical and commercial QA.
- Requires excellent knowledge of US cGMPs and a good understanding of global GMPs.
- Requires experience hosting regulatory inspections.
- Experience in the application and knowledge of phase appropriate quality is required.
- Must have strong leadership, interpersonal, negotiation, presentation and communication skills and ability to build a quality culture within CMC and QS.
- Requires the demonstrated ability to analyze, interpret and compile data, define problems, establish facts, draw valid conclusions and make timely fact-based decisions. Must have extraordinary attention to detail.
- Excellent written and oral communication skills are required; ability to present and defend complex subjects to regulatory bodies.
- Requires the ability to function in a rapidly changing environment & handle multiple priorities.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.