4 Director, Quality Operations Jobs in New York City, NY
Confidential is Hiring a Director, Quality Operations Near New York City, NY
Director, Quality Operations
About the Company
Renowned therapeutics organization developing novel treatments for patients
Industry
Pharmaceuticals
Type
Privately Held
About the Role
The Company is seeking a Director of Quality Operations to lead a small Lab QA team in supporting biologics clinical development and commercial CMC programs. The successful candidate will be responsible for providing quality oversight of analytical testing services performed by various suppliers, managing Lab QA resources, and ensuring compliance with cGMP, regulatory submissions, and quality agreements. This role involves reviewing and approving analytical test results, authoring certificates of analysis, and leading quality and compliance matters related to analytical testing. The Director will also be involved in creating and maintaining quality agreements with suppliers, supporting regulatory inspections, and driving a culture of quality excellence within biologics operations.Candidates for this position should have a minimum of 10 years' experience in GMP QC/QA/Quality Systems, Microbiology, or Analytical Development in the biopharma or pharmaceutical industry, with at least 5 years of direct supervisory experience. A strong background in cGMP for biologics, including experience with CMO/CTO management, is essential. The ideal candidate will have a proven track record of interaction with regulatory agencies, proficiency in electronic QMS software, and excellent communication and leadership skills. Experience in a small biotech setting and with small molecule drug substance and solid oral dosage manufacturing is a plus. The role may require up to 10% travel, including international travel, to meet business needs.
Travel Percent
Less than 10%
Functions
- Operations
- General Management
Job Summary
Per Diem
$176k-213k (estimate)
04/30/2024
05/16/2024
michaelmabraham.com
<25
The following is the career advancement route for Director, Quality Operations positions, which can be used as a reference in future career path planning. As a Director, Quality Operations, it can be promoted into senior positions as a Top Quality Assurance Executive that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Director, Quality Operations. You can explore the career advancement for a Director, Quality Operations below and select your interested title to get hiring information.
