The Manager, CMO & Partner Quality Assurance Validation implements policies and procedures to validate/qualify equipment, systems, and processes for our CMO and partner groups in accordance with regulatory requirements and company manufacturing standards and supervises a team of Validation Specialists.
As a Manager, CMO Quality Assurance Validation, a typical day might include the following:
- Leads cross-functional teams in developing Validation best practices, standards and guidelines which includes exploring new techniques, methods and other industry practices
- Leads and completes projects by developing appropriate plans, schedules, resource loading and other project aspects; based on engineering specification, performs validation projects which include authoring protocols, implementing validation protocols and writing reports of validation results
- Reviews and approves Validation protocols and summary reports generated by the Validation staff against standard operating procedures and policies as well provides mentorship to Validation staff writing protocols and final reports
- Prepares equipment for qualification studies and performs qualification and validation studies according to approved protocols and SOPs
- Leads team of Validations specialist who investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
- Coordinates prioritization of activities with area management.
- Responsible for compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions.
- Reviews internal and external requirements and implements required processes, as needed, to meet expectations regarding Quality.
- Approves various documents relating to area function, including those listed above.
- Provide direction and assign work to Validations Specialists to meet goals and timings
- Participates in regulatory and customer activities.
- Collaborates with functional departments to resolve issues.
- Manages projects and prepares status reports.
This role might be for you if you:
- Have validation or engineering experience in the pharmaceutical industry or similar industries
- Can coordinate with other departments or outside contractors/vendors to complete validation tasks
- Continuously seek to improve processes for improved performance
- Are looking for a great culture! Regeneron has best-in-class onsite and offsite events throughout the year, onsite cafeterias, company affiliated sports teams and clubs, and a culture centered on diversity and inclusion.
To be considered for this role you must hold a BS/BA in Engineering, Chemistry, or Life Sciences and
- Associate Manager: 6+ years of related experience within the field; may consider substituting relevant experience for education.
- Manager: 8+ years of related experience within the field; may consider substituting relevant experience for education.
- Experience leading, supervising, or managing others 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 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.