Manager Investigations (Systems)
We are currently looking to fill a Manager, Investigations (Systems) position. This position is responsible for providing Quality oversight of the review, approval and management of investigations and change documentation. Focuses on preventing recurrence of events that affect operations and/or disposition.
In this role, a typical day might include the following:
• Leading a team with direct oversight of work for deviations, corrective actions and associated change controls
• Reviewing, verifying and approving system records
• Approving and reviewing SOP revisions
• Providing direction for cross-functional study team meetings and interacting with subject matter specialists
• Providing input for error prevention and corrective actions based on investigational findings
• Involved in post-production management of events to facilitate closures to meet the required timelines
• Serving as a specialist to present topics to management and during inspections
• Owning quality system metrics including deviations, corrective actions, change management and controlled document workflows
• Drafting and implementing long-term planning for the process, staff and budget
• Performing personnel management functions (annual employee evaluations, coaching, mentoring, performance feedback)
• Making decisions, developing and implementing policies
• Ensuring that policies and procedures are effectively managed and follow regulatory requirements and current good manufacturing practices
This role might 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 Bachelor's degree in Life Sciences and the following minimum amounts of relevant cGMP manufacturing experience for each level:
• Associate Manager - 6+ years
• Manager - 7+ years
Also 3 years of supervisory experience is required. Level to be determined based on qualifications relevant to the role. May substitute proven experience for education requirement.
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.