Manager, Quality Compliance (Compliant Investigations)
The Manager, Quality Compliance (Compliant Investigations) manages a team responsible for providing quality assurance oversight of site compliance focused primarily on investigation (product quality complaints and/or trend investigations) of cases received for commercially distributed and clinical products. This person will ensure compliance with general day-to-day QA support regarding documentation review and approval and conducts review of evidence and both internal and external records, design of experiments to test hypothesis and writes technical reports and/or protocols to support investigation conclusions. They will also participate in cross-functional team investigations /efforts with other functions such as Manufacturing (Internal and External), Quality Control, Quality Assurance, Global Patient Safety in accordance with mandated regulatory requirements and site expectations. They will act as an advisor to these groups of how to maintain and improve compliance and become involved to meet schedules or resolve problems.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Responsible for ensuring aspects of Quality Compliance for the Rensselaer site inclusive of manufacturing, quality control, validation, facilities, and materials management; this work may be done through direct reports.
- Oversees investigations (product quality complaints and trending) related to dissatisfaction by end user related to commercial and clinical products.
- Provides guidance on investigation plans related to complaints documentations, photographic evidence, return samples and is available support investigations.
- Participates in regulatory and customer audits.
- Identify gaps in systems and develop feasible plans for correction
- Mentor direct reports and functional area counterparts in compliance requirements.
- Facilitating continuous improvement initiatives specific to function.
- Ensuring appropriate training programs are implemented for related to function.
- Other related responsibilities as assigned.
To be considered for this position, you must have a minimum of a BS/BA in scientific subject area or related field with 6+ years of relevant work experience in pharmaceutical or related industry for an Associate Manager or 8+ years of relevant work experience in pharmaceutical or related industry for Manager. In addition, previous experience leading people desirable plus knowledge/exposure to project management, high Proficiency in Microsoft Office programs and excellent organizational skills.
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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.