We are currently looking to fill a Division Manager, Investigations position. This position is responsible for providing oversight of the review, approval and management of investigations and change documentation. Focus 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
May review, verify and approve system records
Approving/reviewing 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 the need arises to facilitate closures to meet the required timelines
Serves as a subject matter authority (SME) to present topics to management and during inspections
Supervises quality system metrics including deviations, corrective actions, changes, and controlled document workflows
Draft and implement long-term planning for the process, staff, and budget
Perform personnel management functions (i.e. annual employee evaluations, coaching, mentoring, performance feedback, etc.)
Make decisions; develops and implements policies
Ensure that policies and procedures are effectively coordinated and align with regulatory requirements and current good manufacturing practices (cGMPs)
This role may be for you if you:
Have previous quality or manufacturing experience in the pharmaceutical industry
You continuously seek to improve processes for improved performance
Enjoy directing 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:
Also must have at least 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 amazing benefits including health and wellness programs, fitness centers and stock 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.