Description

Job Description

The Associate Director, Quality Control within our Research and Development Division Device Quality & Regulatory is responsible for providing QA/QC oversight of the company's Device Network design verification laboratories. This role will provide quality oversight for the qualification, calibration and maintenance of analytical laboratory instruments and equipment, method validation, and associated documentation for design verification laboratories in Rahway and the Center for Packaging & Device Analytics (CPDA).

Key responsibilities include:

1. Serve as quality oversight for design verification laboratories:

• Quality oversight for qualification, maintenance and calibration of laboratory equipment, instrumentation and test methods used to support design verification.
• Provides quality approval for applicable equipment validation protocols and reports, test method validation protocols and reports, change controls, deviations and CAPA.
• Ensures procedures used by design verification laboratories align with Good Laboratory Practices, Good Documentation Practices, and applicable regulatory requirements
• Provides support for internal audits and regulatory agency audits.
• Promotes awareness of applicable regulatory requirements and QMS requirements for design verification laboratories

2. Ensure compliance with data integrity expectations:

• Leads implementation of ALCOA+ principles for data generated by the design verification laboratories
• Supports establishment of controls for computer system administration, data archival and data retention

3. Leadership and Personnel Management:

• Provide strategic direction, mentorship, and development opportunities to personnel

Required Education, Experience and Skills:

• Bachelor of Science in relevant scientific discipline
• 5 or more years of experience in quality laboratory operations
• Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills
• Familiarity with device design verification and design control aspects
• Experience supporting internal and external audits

Required Skills:
Biological Analysis, Continuous Improvement Tools, Counterfeit Detection, Good Documentation Practices, Good Laboratory Practices (GLPs), Identifying Customer Needs, Internal Auditing, Lab Equipment Maintenance, Laboratory Analysis, Laboratory Equipment Calibration, Laboratory Operations, Microbiological Analysis, Proper Documentation, Quality Control Management, Quality Management, Quantitative Assay, Regulatory Awareness, Regulatory Compliance, Regulatory Requirements, System Administration, Technical Transfer, Validation Protocols

Preferred 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. Please click here if you need an accommodation during the application or hiring process.

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. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

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

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is
$126,500.00 - $199,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: 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.

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
25%

Flexible Work Arrangements:
Hybrid

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
01/20/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R378833