Msd
Associate Director, Laboratory Operations, Logistics and Safety Compliance (Onsite)
USA - New Jersey - Rahway · Director · Contract
Sponsorship not specified$142k-$224kDetected 2 days ago
ComplianceUX ResearchStakeholder ManagementLogisticsHRISFDA RegulatoryMedical DevicesLeadershipCollaborationOSHARegulatory Affairs
About the role
- This role is critical in enabling safe, compliant, and efficient laboratory environments that accelerate the development of innovative medicines and medical devices for patients worldwide.
- Please click here if you need an accommodation during the application or hiring process.
- The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment.
Responsibilities
- Manage equipment lifecycle processes, including qualification, calibration, maintenance, and decommissioning.
- Lead safety programs addressing device-specific hazards (e.g., mechanical systems, electrical testing, prototyping equipment, usability testing).
- Drive proactive risk assessments, incident investigations, and CAPA implementation.
- Partner with R&D and engineering teams to support design verification and validation (DV/V), human factors studies, and device testing activities.
- Support regulatory inspections and audits (e.g., FDA, notified bodies) for device and combination product programs.
- Collaborate with Facilities and Engineering to maintain compliant laboratory infrastructure, including specialized device labs and test environments.
- Ensure appropriate layout, safety controls, and environmental conditions are in place to support device development workflows.
- Lead, coach, and develop a team responsible for lab operations and safety.
Requirements
- Bachelor's degree in Engineering, Life Sciences, or related discipline (advanced degree preferred).
Nice to have
- FDA Quality System Regulation (21 CFR Part 820)
- ISO 13485 and applicable device standards
- OSHA/EHS requirements for laboratory and engineering environments
- Experience supporting combination product (drug-device) development programs.
- Familiarity with human factors/usability laboratory environments.
- Professional certification in EHS, safety engineering, or quality systems.
- Strategic thinking and decision-making
- Strong collaboration and stakeholder management
Skills
- Current Employees apply HERE
- Current Contingent Workers apply HERE
- US and Puerto Rico Residents Only:
- Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
- EEOC Know Your Rights
- EEOC GINA Supplement
Compensation
- The salary range for this role is
Benefits
- Provide strategic and operational leadership for laboratories supporting medical device and combination product development.
- Medical device or drug-device combination product environments
Company info
- As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
- As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
- For more information about personal rights under the U.S.
- We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
- Search Firm Representatives Please Read Carefully
- Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
- All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.
- No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.
- Where agency agreements are in place, introductions are position specific.
- Please, no phone calls or emails.
Equal opportunity
- Employment laws, visit:
- We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
- Learn more about your rights, including under California, Colorado and other US State Acts
- The salary range for this role is
Visa & Work Authorization
- VISA Sponsorship:
This listing is sourced directly from Msd's careers page and normalized into a canonical job model.