We are currently looking to fill a Manager, QA Investigations position. This position is responsible for providing oversight of the quality review, quality approval and management of IOPS events, investigations and CAPA.
In this role, a typical day might include the following:
Manages a team with direct oversight of review and approval for deviations, laboratory investigations and corrective actions.
May review, verify and approve system records.
Collaborates across QA to provide succinct support to investigation teams to drive quality outcomes.
Approves and reviews SOP revisions.
Provides direction for cross-functional study team meetings and interacts with subject matter authorities.
Provides input for error prevention and corrective actions based on investigational findings.
Involved in post-production management of events as required to facilitate closures to meet the required timelines.
Serves as a subject matter authority to present topics to management and during inspections.
Monitors quality system metrics including deviations, corrective actions, change management and controlled document workflows.
Drafts and implements long-term planning for the process, staff and budget.
Performs personnel management functions (i.e. annual employee evaluations, coaching, mentoring, performance feedback, etc.).
Makes decisions and develops and implements policies.
Ensures that policies and procedures are effectively coordinated and follow regulatory requirements and current good manufacturing practices (cGMPs).
This role may be for you if you:
Have previous quality experience in the pharmaceutical industry
You continuously seek to improve processes for improved performance
Enjoy leading a team of Quality minded professionals
To be considered for this role you must hold a BA / BS degree in Life Sciences or related field and the following minimum amounts of relevant cGMP manufacturing experience for each level:
Associate Manager – 6+ years
Manager – 7+ years
Also, must have 3 years of supervisory experience. May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
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)