Associate Director, Quality Assurance

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a Safety First Quality Always mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials intermediates and finished products.

Our ability to excel depends on the integrity knowledge imagination skill diversity and teamwork of an individual like you. To this end we strive to create an environment of mutual respect encouragement and teamwork. As part of our global team youll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Under the general supervision of the Executive Director Quality Operations the Associate Director is responsible for Quality Assurance including but not limited to :

• Change control
• Batch record review and release
• Packaging and vendor investigations
• Component and bulk release
• Defect resolution
• Retention
• SAP master data
• Site wide internal and external audits
• Regulatory document reviews
• Product complaint management
• New product introductions and other Quality Assurance related functions.

The Associate Director Quality Assurance will oversee a staff of approximately 5 15 employees which typically consists of Associate Specialists Specialists and Senior Specialists responsible for Quality Assurance.

Primary activities may include but are not limited to the following :

Education Minimum Requirement :

Required Experience and Skills :

Preferred Experience and Skills :

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities along with our external contractors suppliers and partners create an interdependent global manufacturing network thats committed to delivering a high quality reliable supply to customers and patients on time every time.

Required Skills :

Accountability Accountability Administrative Policies Animal Vaccination Batch Releases Change Management Communication Computer System Validation (CSV) Decision Making Driving Continuous Improvement GMP Laboratory Good Manufacturing Practices (GMP) Human Resources Policies Management Process People Leadership Performance Qualification (PQ) Quality Assurance (QA) Quality Auditing Quality Control Documentation Quality Control Management Quality Management Quality Management Standards Quality Management Systems (QMS) Quality Risk Management Regulatory Compliance 4 more

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 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 anothers 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 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

$139600.00 - $219700.00

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 employees 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 can apply for this role through (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 :

10%

Flexible Work Arrangements :

Not Applicable

Shift : 1st - Day

Valid Driving License :

No

Hazardous Material(s) :

n / a

Job Posting End Date :

11 / 12 / 2025

Required Experience :

Director

Key Skills

Quality Assurance,FDA Regulations,ISO 9001,Root cause Analysis,Biotechnology,Clinical Trials,Quality Systems,Food Processing,Quality Control,Quality Management,cGMP,HACCP

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 139600 - 219700