Associate Director, Quality Assurance (Product Complaints)

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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.

Level to be determined based on qualifications relevant to the role.

Summary: Directs and oversees product compliance associated with commercial and clinical investigational products in accordance with mandated regulatory requirements and site expectations. Oversight of complaint investigations, conducting gap assessments of the current product complaint procedures to the applicable regulations, developing staff on handling of product complaint investigations.

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

• Manage and develop the group responsible for handling product complaints for commercial and clinical investigational products.

• Manages global clinical and commercial compliant management process

• Leads and co-ordinates complex complaint investigations, including development and implementation of corrective actions

• Interfaces with regulatory agencies as required, representing Regeneron to authorities and regulatory inspectorates. Prepares and presents data to the regulatory agency during inspections

• Evaluate and approve product complaints by reviewing written investigations, evaluations, and responses to customer complaints to identify root causes, develop mitigation, and remediation plans

• Identify and escalate potential critical quality concerns coming from product complaints to leadership

• Interacts with customers through senior management during complaint process.

• Manage high level complex complaint investigations.

• Collaborate with the Pharmacovigilence group to correlate Adverse Events.

• Interpret compliance requirements for incorporation into company systems and procedures.

• Participate in regulatory and customer audits.

• Actively participate in company continuous improvement initiatives.

• Identify gaps in complaint handling process as it relates to reporting and metrics.

• Monitor trending to maintain seamless compliance and develop feasible plans for correction and preventative actions associated with findings.

• Prepare written reports to management on findings

• Involvement with investigations and/or product complaints with focus on Root Cause Analysis (RCA).

Knowledge, Skills and Abilities:

• Ability to maintain integrity and honesty at all times

• Ability to work independently or as part of a team

• Ability to communicate and lead with transparency

• Continuously drive to improve processes for improved performance

• Demonstrate respectful behavior at all times

• Lead department for optimal performance and set course for future

• Accountable for performance and results of department

• Business continuity and long-term planning

• Ability to influence outside of own department

• Create departmental goals and assign resources based on business needs

• Effectively communicate vision for department

• Evolving knowledge of global organization and industry trends

Education and Experience:

• Requires BS/BA in scientific discipline or related field with 10+ years of relevant work experience in pharmaceutical or related industry, and experience with complaint handling practices.

• Experience with product complaint regulations and performing investigations within quality systems.

• Must have strong knowledge of CGMP (FDA, EU and ICH) requirements, FDA/EU regulatory guideline

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, disability status, protected veteran status, or any other characteristic protected by law.
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