Associate Director, External Manufacturing Compliance

Rensselaer, NY, United States
Nov 21, 2020
Required Education
Bachelors Degree
Position Type
Full time
We are currently looking to fill an Associate Director External Manufacturing Compliance position. This position will supervise a group that supports compliance activities associated with all products manufactured in the manufacturing network in accordance with mandated regulatory requirements and site expectations. The Associate Director will establish standard methodologies in all compliance related activities, collaborate and partner with quality compliance groups, define and lead metrics and manage External Manufacturing cGMP Policies and SOPs.

In this role, a typical day might include the following:
• Leading and prioritizing operations and practices for supporting deviation investigations, as well as implementing CAPAs and Change Controls for manufacturing
• Developing, training and mentoring team members to lead or support investigations to identify root causes and robust corrective and preventative actions by utilizing root cause analysis tools
• Offering feedback and collaborating with technical SMEs to pressure test conclusions, duties and responsibilities
• Providing input and participating in long term critical initiatives which enable growth and ensure External Manufacturing meets the emerging needs of our patients
• Collaborating to address observations and drive CAPAs to completion
• Providing expertise to the global External Manufacturing organization on cGMP compliance, standard methodologies as well as new and developing cGMP requirements and trends
• Reviewing and maintaining procedures, polices and other instructional documents with a focus on continuous improvement
• Responsible for generating and improving metrics in critical compliance activities
• Partnering with Quality Assurance and External Manufacturing Drug Product and Drug Substance Manufacturing Teams with critical contract manufacturers to resolve compliance issues in clinical and commercial supply chains and works with customer/partner quality organizations
• Requesting and supporting audits of new and existing External Manufacturing partners
• Supporting partner sites in devising and executing remediation actions to ensure compliance to Regulatory and Regeneron's expectations and requirements
• Providing advice and on-site support to Partner sites during inspections and customer audits as requested by External Manufacturing Leadership Team
• Providing support to internal Regeneron audits and support for Regeneron IMT as a contact during Regulatory inspections of Regeneron sites
• Supporting regular analysis of regulatory observations made at Regeneron's External Manufacturing sites, prepares and coordinates the global follow-up/gap analysis to prevent re-occurrence
• Assisting in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at external manufacturing contract manufacturers
• Counseling employees about work performance and conducting hiring and discharge interviews
• Traveling up to 25% (domestic and international)

This role may be for you if you:
• Have detailed knowledge of cGMPs and cGLPs
• Demonstrate a proactive approach to issue resolution with an ability to work well across various departments as well as business partners
• Possess excellent interpersonal, cross-cultural, communication and problem-solving skills.
• Have experience interacting with Contract Manufacturing Organizations
• Are knowledgeable in industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.)

To be considered for this role you must hold a Bachelor's degree in a scientific subject area and at least 10 years of related experience in the pharmaceutical/biotech industry, including sterile and aseptic manufacturing experience, experience working in Compliance, Quality Assurance or Manufacturing and experience in a managerial capacity within Compliance/QA/QC, or equivalent combination of education and experience. Competent in German, French and/or Spanish (oral and written) is a plus.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.