Compliance Manager, Drug Product Manufacturing

Location
Rensselaer, NY, United States
Posted
Jun 30, 2019
Ref
16590BR
Required Education
Bachelors Degree
Position Type
Full time
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: The Manager of Drug Product Manufacturing Compliance will lead and coordinate the activities associated with investigations, CAPAs and change controls for all drug product manufactured in the Regeneron's DP Manufacturing network. The Manager will establish best practices in all compliance related activities, define and manage key metrics and manage DP Manufacturing cGMP Policies and SOPs. This is a leadership role that requires excellent communication, collaboration and problem-solving capabilities.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Lead and prioritize operations and practices for deviation investigations, CAPAs, and Change Controls for clinical and commercial drug product manufacturing.

• Develop, train and coach DP Manufacturing specialists to lead investigations to identify actionable root causes and robust corrective and preventative actions by effectively utilizing advanced root cause analysis tools.

• Request and support audits of new and existing DP Manufacturing partners. Collaborate with Quality Assurance and DP Manufacturing Teams to effectively address observations and drive CAPAs to completion.

• Provide expertise to the global DP Manufacturing organization on cGMP compliance, best practices as well as new and developing cGMP regulatory requirements and trends.

• Review and maintain procedures, polices and other instructional documents with a focus on continuous improvement.

• Responsible for generating, tracking and improving key metrics in critical compliance activities.

• Collaborate with Drug Product Manufacturing teams, Quality Assurance and Regulatory groups to define and address all issues of non-compliance within the DP Manufacturing network.

• Advise and support the sites in devising and executing remediation actions to ensure compliance to regulatory and Regeneron's expectations and requirements.

• Provide advice and on-site support to sites during regulatory inspections and customer audits as requested by DP Manufacturing Leadership Team.

• Support regular analysis of regulatory observations made at Regeneron's DP Manufacturing sites (external and internal), prepare and coordinate the global follow-up/gap analysis to prevent re-occurrence.

• Assist in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers.

• Travel < 25% is required (domestic and international).

Knowledge, Skills, and Abilities:

• Demonstrated proactive approach to issue resolution with an ability to work well across various departments as well as business partners.

• Excellent interpersonal, cross-cultural, communication, negotiation and problem-solving skills.

• Good knowledge of industry practices and regulations (e.g. GxP, ISO, ICH, etc.) across multiple health authorities (e.g. FDA, IMB, etc.)

• Experience interacting with Contract Manufacturing Organizations.

• Demonstrated technical expertise in drug product manufacture and/or product development and validation.

• Knowledge of industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.).

• Strong project management, interpersonal, cross- cultural, communication, negotiation and problem-solving skills qualification preferable.

• Fluent in English with a preference given to candidates with competencies in German, French and/or Spanish (oral and written).

Education and Experience:

• Associate Manager level - BS/BA in engineering or scientific related field with 8+ years of related professional experience in a cGMP environment or in the operation of an industrial facility (Masters 7+ years, PhD 2+ years).

• Manager level - BS/BA in engineering or scientific related field with 10+ years of related professional experience in a cGMP environment or in the operation of an industrial facility (Masters 9+ years, PhD 5+ years).

• Minimum of 5+ years' experience working in an aseptic parenteral filling operation cGMP environment.

*Level will be determined based on skills and related experience.*

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.
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