Senior Manager / Manager Quality Auditing

Rensselaer, New York
Apr 26, 2018
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Responsible for providing professional expertise, leadership, oversight and strategic planning for the Regeneron IOPS Quality Auditing function, with primary emphasis on GMP, IT and Quality audits that may impact GMP operations and/or product. Quality (GMP) Auditing is responsible for maintaining the internal and external audit programs and performing internal and external audits for Regeneron IOPS. This individual is responsible for ensuring auditors have the education, experience and/or training necessary to be able to identify compliance issues and negotiate resolution in a highly autonomous manner. Additionally, this individual is responsible for managing relationships with Procurement, External Manufacturing, Quality and other stakeholders as they pertain to external audits.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Maintain professional expertise and knowledge of audit criteria including, but not limited to, internal company policies and procedures, and applicable local and international regulations, standards and guidelines (e.g., Chapter 21 of the Code of Federal Regulations, Eudralex Volume 4 and associated Annexes, ISO Standards, and ICH, WHO and IPEC Guidelines, etc.);
• Monitor and communicate industry trends as they pertain to regulatory agency findings, expectations and warning letters;
• Collaborate with Procurement, External Manufacturing, Quality, and other stakeholders and audit clients pertaining to supplier audits;
• Oversee and manage the IOPS internal and external audit programs and audit schedules for GMP, IT and quality audits;
• Strategically plan, prioritize and manage resources to meet audit schedules, company and departmental goals and objectives, and quality deliverables;
• Provide guidance and direction on auditing matters, and provide leadership, guidance and supervision to auditing personnel; Promote a GxP and Quality mindset at all levels;
• Plan, lead and perform audits as necessary;
• Oversee the selection, training, onboarding and audit performance of consultant auditors;
• Coach, develop and mentor Quality (GMP) Auditing employees to drive succession planning and business continuity planning;
• Compile, organize, and present Right to Operate (RTO) metrics to senior management for all areas of responsibility;
• Ensure auditing processes and procedures meet the minimum regulatory requirements and current industry standards and expectations and are followed; if deviations or changes occur ensure they are documented in accordance with IOPS processes and procedures.
• Reassess auditing processes and procedures periodically for continuous improvement opportunities to ensure optimal performance; continually raise the bar in a strategic and thoughtful manner;
• Ensure the training and qualification program for auditing employees is appropriate and adequately maintained;
• Accountable for the performance and results of the Quality (GMP) Auditing Department;
• Participate in inspection readiness and inspections as needed;
• Ensure safety and operational standards are maintained.
Education and Experience:
• BS or higher degree in life sciences discipline or related field (chemistry, biology, or pharmacy preferred);
• Minimum of 12 years pharmaceutical/biotechnology industry experience; experience with Quality Systems and auditing required;
• 7+ years managerial experience required.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

Requisition Number: 12642BR