Job Seekers

Senior Manager Quality Control

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$125,000 - $150,000
Job Type
Direct Hire
Bachelor of Science
Jan 04, 2017
Job ID
Seeking experienced head of cGMP Quality Control to provide leadership and successful execution of analytical development and quality control functions across the drug product lifecycle (in support of animal studies, clinical studies and commercial distribution). The Senior Manager of QC will provide active leadership, subject matter expertise, and project management and will report to the site Director of Quality(offsite). The successful candidate will have experience in a commercial pharmaceutical manufacturing environment and demonstrated leadership to QC laboratories in order to support all analytical needs and ensure successful CGMP compliance. This is an exciting opportunity to join a successful, growing company in a key role. Responsibilities:• Manage QC staff (~30 and growing) provide subject matter expertise for QC lab, personnel, instruments, equipment, data systems, and customers• Provides leadership to managers, supervisors and/or professional staff• Is accountable for the performance and development of departmental plans, including business and organizational priorities• Looks beyond existing methodologies and own discipline to define and resolve complex problems• Ensure QC decisions align with Quality System, GMP and regulatory requirements. Recommend QC strategic objectives• Demonstrate technical proficiency in analytical methodology and adherence to GMP and ICH compliance for drug products distributed globally• Collaborate with client and regulatory to support IND/NDA/MAA filings/amendments on CMC sections• Evaluate resource requirements to support projects and assure projects remain within budget• Train direct reports on QC job related functions and establish and review department training curriculum to ensure a comprehensive laboratory training plan• Support regulatory PAI and GMP inspections in a global environment• Lead QC continuous improvement initiatives including implementation of new methods and equipment• Track QC metrics and takes appropriate action to improve lab performance• Represents QC on the overall design of Quality Systems and on cross-functional project teamsBS/MS/PhD w/15 years experience in QC or equivalent experience in commercial pharmaceutical industry; 5+ years in a management role, particularly in a commercial GMP environment• Expertise in analytical method development, analytical method validation, and statistical quality control• Excellent knowledge of GMP, ICH, USP and global compendial regulations and guidance• Strong leadership and project management skills required to support a multi-client environment from small biotech through big pharma

Unless noted above, applicants MUST be authorized to work in the US without Visa Sponsorship. US citizens and Green Card holders ONLY. We do not provide relocation assistance for those living outside the continental US. Please only click apply if you meet the specific requirements of the job listing, you are able to work in the location listed, and are comfortable with the salary range indicated above. Thanks for your interest. We look forward to working with you.