Regeneron is looking for an Associate Manager QC (Quality Control). This position is part of the QC Compliance team, supporting QC Chemistry Day 1 and HPLC lab. The Associate Manager will have direct oversight of a crucial personnel team supporting a 24/7 operation. We are looking for someone that can balance the needs of the team and the business. The ideal candidate will help drive improvements in KPIs, metrics, and team performance, with a focus on efficiency, continuous improvement, and compliance. They will be responsible for routine operations and ensure all daily tasks, expectations, and responsibilities are met.
As an Associate Manager QC , a typical day might include the following:
- Ensure adherence to GMP’s/regulatory requirements and help maintain an overall state of compliance.
- Act as a QC Lab, quality, and compliance subject matter expert, driving risk-based actions and improvements, in alignment with the strategic direction of the QC organization and the company.
- Foster collaboration and serve as a key member of the QC Chemistry group, providing quality leadership, mentorship, and direction to achieve company and departmental goals.
- Responsible for ensuring adherence to Quality Management Systems, and ensuring robust investigations are performed.
- Identify, maintain, and lead overall compliance activities across the group.
- Help drive investigations & corrective actions, and improvements to ensure detailed investigations, product impact assessments, identification of the root cause, and implementation of corrective actions to mitigate recurrence.
- Contribute to design control and risk management for data workflows, within the context of data integrity and data governance.
- On-board, coach, and mentor new team members. Coordinates with members of Manufacturing, Stability, and Business Ops to provide analytical support.
- Leads all aspects of product testing and QC lab investigations.
- Reviews test reports, data, and investigational test plans.
- Attends meetings to keep informed of manufacturing priorities, and plans accordingly.
- Ensures compliance with applicable cGMP regulations and SOPs.
- Investigates atypical test results as needed.
- Crafts monthly testing reports.
- Performs personnel management functions including time sheet submissions, scheduling of vacations, personnel development/feedback and, performance evaluations.
This role might be for you if you:
- Excel at critical thinking and problem-solving.
- Feel comfortable having challenging conversations and providing feedback.
- Can communicate clearly, and lead with compassion and understanding.
- Possess strong operating skills, decision-making, and managing a diverse team, with good overall time and project management.
- Strong communication skills with the ability to influence, and engage at all levels of the organization, encouraging a collaborative and inclusive environment.
- Are solutions-oriented, with strong analytical, critical thinking and problem-solving skills.
- Are comfortable working in a fast-paced, highly dynamic environment.
- Adaptable and flexible, and a quick learner in support of continuous improvements and team culture.
To be considered for the Associate Manager Quality Control you must be willing and able to work Monday- Friday, 8am-4:30pm. You must have a BS/BA in Life Sciences, or a related field, Chemistry and Biochemistry preferred and 6+ years of relevant experience. Leadership experience is required.
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.
Salary Range (annually)