Quality Recruiting. Established Experts.
Director, Quality Control
Reference Number: 2871
Location: West Coast
Our client is a biopharmaceutical company whose mission is to develop effective therapies to treat and cure cancer. They have asked us to assist them in their search for a Director, Quality Control.
The Director, Quality Control is responsible for directing the development, implementation and administration of Quality Control (QC) activities, personnel, systems, procedures, and programs to ensure the quality and reliability of clinical materials and commercial products, as well as Quality Control for cGMP, GLP and GCP processes and systems for the company.
Major tasks and responsibilities will include:
- Leadership and management responsibility for the QC review and oversight of development, testing, stability and validation data, documentation, and records relating to the sampling, testing, analysis, and investigation of clinical and commercial drug materials.
- Manages and leads all QC Staff, and acts as the QC technical representative and highest level QC contact with analytical vendors, Quality Assurance, and Regulatory Affairs, and will report directly to the Senior Vice President, Global Quality.
We seek candidates with the following qualifications:
- Bachelor’s degree in a scientific discipline such as chemistry, biology, microbiology, or similar is required. Advanced and/or Doctorate degree in a scientific discipline preferred.
- ASQ Certification such as Certified Quality Engineer (CQE) preferred.
- Minimum of 15 years of experience in an FDA-regulated pharmaceutical environment performing QC functions, with a minimum of 10 years in a supervisory QC Laboratory management capacity, in analytical and quality control GMP pharmaceutical environment.
- Experience managing quality control technical systems in an FDA-regulated environment required.
- Experience working with aseptic pharmaceutical products/compounds.
- Preference given to an existing QC Lab Manager or QC Director currently managing a QC Laboratory in a pharmaceutical, biotech, or medical device company.
- Experience with Novatek systems preferred.
- Strong experience and training in Statistical Techniques and Methods, Statistical Process Control (SPC), Statistical Quality Control (SQC), Trend Analysis, Proactive QC Methods.
- Experience managing the QC Requirements and QC Vender Oversight for Contract Manufacturing Organizations (CMOs), and Contract Laboratory Organizations (CLOs).
Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2871. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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- Director New Product Commercialization, Major Global Pharmaceutical Company
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- Manager Field Analysis, Major Global Pharmaceutical Company
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I have worked and dealt with a number of recruiting companies, but I have to say this has best my best interaction ever.
- Medical Director Imaging, Major Global Diagnostic Imaging Company
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Christopher is highly professional, energetic and efficient. He knows the pharmaceutical industry and was great at understanding my needs...
- Manager Outcomes Research, Major Global Pharmaceutical Company
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- Director Drug Product Technology
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Jan is a true partner in the talent acquisition business. She is genuinely interested in making certain her clients are positioned to ensure long-term success for both parties. As a candidate, in preparation for the interview process, Jan was quickly able to provide me information about the position, the company, their culture, and key leadership profiles, ensuring I could best represent myself and critical skills and experiences that I brought to the table. Jan made sure all of my questions were immediately answered with quick and responsive communication. After accepting the position, Jan and I remain in contact today and she is always available to provide continued support and employment advice. She now provides me with recruiting assistance for my department and continues to remain true to form in assisting in the process on the employer’s side, while identifying the best talent for our needs.
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Dear Jan, I cannot thank you enough for all the help and support you gave throughout the selection process, and most recently the hiring and relocation process with [name of company]. I have enjoyed working with you and am very grateful to you. I am extremely excited to start next week!
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Just wanted to take a quick moment to say thank you for all of your insights and coaching during my placement process at Novartis. I’m delighted to be joining such a wonderful team.
- Manager Field Analysis, Major Global Pharmaceutical Company
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Dear Jan, I cannot thank you enough for all the help and support you gave throughout the selection process, and most recently the hiring and relocation process with [name of company]. I have enjoyed working with you and am very grateful to you. I am extremely excited to start next week!
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I wanted to thank you for initial contact and support through the selections process with AbbVie. I greatly appreciated you championing me and submitting me for consideration. I am very excited to start my new job!
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Thank you for managing my recruitment to AbbVie for the Associate Director, Global Project Management position. I appreciate all the efforts that you and your company accomplished in helping me secure this new opportunity. Please know that I would never have known about this opportunity or pursued it without the persistence of Chris. It was your ability with Human Resources and the hiring manager at AbbVie that expedited and helped secure this position for me—I could not have done this without you. Thank you very much!
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Lee Golodny was the recruiter who eventually placed me at my new job. I was looking for a new career opportunity but had not had any success on my own with my networking. Lee contacted me through LinkedIn about a potential job at a small biotech firm. We discussed at length what I was looking for and he walked me through the process. He was very professional and I was impressed with him during the entire process. He followed up with me after every phone call, informal meeting, prepped me for the interview and helped me land a really great opportunity. Looking for a new job can be stressful but he made the process much easier for me. I hope others who may need that extra help will approach Lee to assist them in their job search.
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