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We are currently looking to fill an Associate Manager, Quality Control Compliance position. This position is responsible for QC compliance and business operation in the following (but not limited to) 3 quality system areas: the deviation system, the documentation & change control, and the data review function.
In this role, a typical day might include the following:
• Facilitating the deviation management and compliance challenges in QC (adherence to closure timeline per corresponding SOPs). Collect and analyze metrics related to QC deviations (NOE, GLIFs, EOEs. DNFs) and derived CI. Own the revision of all deviation related SOPs. Own the periodic review of the deviations.
• Supporting all QC groups in documentation management and change control procedure and supervises change control closure and derive CIs.
• Oversight of the QC Analytical data review function supervising laboratory due dates to ensure timely disposition of batches. This is including organizing work schedules and assigning work to members of the data review team.
• Owning the inspection readiness activities in QC which include Lab walkthroughs, and periodic review of compliance elements such as Training, GLIFs, OOS, batch records and CoAs, electronic systems part 11 compliance etc. Supervise the CAPAs and ensure closure.
• Supervising the group operation and provide mentorship and support to employees. Monitors employees training to ensure that all requirements are met; Maintain up to date training records for self and direct reports.
• Performing personnel management functions including time sheet approvals, scheduling of vacations, employee development, and employee evaluations.
This role might be for you if you have:
• General quality control laboratory (biochemistry, microbiology and/or wet chemistry) and cGMP documentation/compliance knowledge
• Excellent written, verbal and interpersonal communication skills and the ability to effectively interact with all levels to communicate negative information and offer solutions
• Ability to effectively interact with regulatory inspectors
• Attention to detail and investigational, problem solving and interpersonal skills.
• Ability to handle multiple projects and changing priorities with organizational and time management skills.
• A positive, proactive approach to drive projects/tasks to completion
To be considered for this role you must hold a Bachelor's degree in chemistry, biology or related field, previous supervisory experience and the following amount of relevant experience for each level:
• Associate Manager - 6+ years
• Manager - 7+ years
Equivalent combination of education and experience may be considered.
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.