Associate Manager Compliance (Engineering and Automation)

Location
Rensselaer, NY, United States
Posted
Aug 30, 2020
Ref
20463BR
Required Education
Bachelors Degree
Position Type
Full time
Summary

Responsible for overseeing a team of Engineering and Automation Compliance Specialists in the Rensselaer Technical Operations Engineering department that manages deviation investigations, implements Corrective and Preventive Actions (CAPA), supports regulatory inspections, authors SOP and Life Cycle Documentation, facilitates change controls, as well as other compliance tasks/functions.

Responsibilities
• Responsible for ensuring training, development, and compliance of direct reports.
• Sets priorities for Engineering Compliance department.
• Tracks progress on Engineering quality system deliverables, including deviation investigations, CAPAs, and change controls, ensuring quality and accuracy of documentation and adherence to due dates.
• Provides tracking and trending of compliance activities (ex, change controls, investigations, corrective and preventive actions) and other compliance metrics for the Engineering department.
• Interfaces regularly with Quality Assurance, Automation, Manufacturing, Facilities, and other functional areas to facilitate decisions pertaining to quality system deliverables.
• Performs and supports investigations and root cause analysis for equipment-related and compliance-related events.
• Owns change controls on behalf of subject matter experts and interprets testing requirements based on technical documents provided by subject matter expert.
• Develops and updates departmental policies, Standard Operating Procedures, Work Instructions, Job Aids, System Design Specifications, and Equipment Specifications.
• Evaluates Engineering department systems and processes for adherence to cGMPs and industry best practices, and implement changes/improvements as needed.
• Acts as a liaison between Engineering and Quality/Regulatory groups to address compliance-related items.
• Facilitates and/or assists Engineering Department in preparation of regulatory inspections.
• Acts as a department liaison during regulatory inspections and coordinates post-inspection activities.

Requirements
• Requires BS/BA or higher in engineering and 6+ years of related experience working in a cGMP environment or in a regulated industrial facility. Or equivalent combination of education and experience.
• Direct experience with biopharmaceutical process equipment and 2-3 years of experience in a leadership role is preferred.
• Solid leadership and project management skills with demonstrated track record of effective supervision of technical personnel.
• Excellent interpersonal, written, and oral communication skills.
• Ability to manage multiple tasks and meet deadlines with a high tolerance for ambiguity.
• Thorough knowledge of GxP, CFR, and other regulatory requirements.
• Thorough knowledge of cGMPs and quality system requirements.
• Working knowledge of word processing, spreadsheets, database management software, and PCs.

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.

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