As a Supervisor in QC Compliance you will manage a team to oversee all inputs into QC quality systems including laboratory invalids, general investigations, deviations, deviation trending and support inspection readiness items.
Responsible for reporting of quality system metrics to the wider Quality Control group and identifying improvements that can be made in all quality system inputs.
As a Supervisor in QC Compliance a typical day might include, but is not limited to, the following:
- Manage team to ensure that all activities related to non-conformity trend signals and non-conformity investigations are performed in a timely manner, in compliance with Regeneron procedures and regulatory requirements.
- Design and develop QC strategy for resolving investigations, and OOS/OOT results.
- Report and present on Quality Control deviation metrics to Management Team, IOPS organisation and regulatory agencies as required.
- Manage Quality Control personnel in meeting timelines associated with deviation investigations.
- Manage notification of signal monitoring process for QC and provide feedback to Quality Control personnel on trends that have been identified within the quality system.
- Actively Manage the development of the Compliance Team to understand quality system inputs and provide support to Quality Control personnel in completing tasks.
- Support Quality Control’s coordination of subject matter experts during regulatory inspections.
- Support co-ordination of inspection outcomes and associated responses where necessary in accordance with the required timelines.
- Manage the preparation and delivery of the local Right to Operate Quality Control information.
- Review investigation reports that include recommendations on investigation findings for medium/high severity non-conformities.
- Monitor QC processes to acquire vital data in support of investigations and track efficiency of changes.
- Gather data, trend, and analyze QC processes to drive consistency and timeliness.
- Manage training of new employees on investigative processes, techniques, and audit readiness.
- Represent QC on interdepartmental teams and in meetings.
- Support the activities of other departments across IOPS when relevant to QC control.
- Strive for continuous improvement in Laboratory practices to foster GMP compliance and meet different regulatory expectations.
- Perform job duties with little direction from Manager.
- Support other duties assigned by QC Senior Management.
To be considered for this opportunity you should have a BS in Chemistry, Biology, or related field with 5+ years experience in quality control/quality assurance required or equivalent combination of education and experience. Previous supervisory/leadership experience required.
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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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.