Associate Director - Quality Assurance

Merck; Rahway (NJ); Hybrid; USD 129,000 - 203,000; Full time

Job summary

Merck in Rahway, NJ is seeking an Associate Director of Quality Assurance to lead quality operations for facilities, validation, and low bioburden environments supporting clinical development. You will oversee GMP QA activities, drive design-to-start-up quality, and maintain compliance across projects while partnering with cross-functional teams.

The role requires building strong relationships, delivering pragmatic solutions in a fast-paced environment, and guiding capital projects through

Qualifications

• Bachelor’s degree in science, engineering, or related field.
• Minimum of 8 years’ experience in Pharmaceutical/Biotechnology with cGMP knowledge and related functions.

Responsibilities

• Manage Quality oversight of GMP facilities and related assets.
• Lead QA activities for qualification and validation of facilities, equipment, and automation.
• Provide Quality oversight of GMP processes including calibration, change management, risk management, batch review, and investigations.
• Support capital asset lifecycle from design through start-up to compliant manufacture and testing of clinical material.
• Build collaborative relationships and communicate across organizations.
• Identify efficiency opportunities and implement value-added solutions.
• Demonstrate a Quality mindset balancing operations with compliant solutions.
• Ensure industry best practices are applied to new GMP facilities and equipment.

Skills

Compliance Investigations

Conflict Management

Cross-Functional Project Management

Deviation Management

GMP

Operational Quality

Project Leadership

Project Life Cycle Management

Project Risk Assessments

Quality Assurance Systems

Quality Auditing

Quality Management

Quality Oversight

Quality Risk Management

Quality Systems Compliance

Regulatory Compliance

Strategic Thinking

Education

Bachelor’s degree in science/engineering or related field

Job description

Job Description

• Execute GMP quality assurance activities directly related to facilities, equipment, and automation for clinical trial material supply capabilities.
• Support the design phases and operational readiness of one or more cross-modality capital projects that are aligned with the expanding site mission.
• Drive quality from design through qualification, start-up, and operations of new facilities as well as maintain and sustain existing operations and facilities.
• Develop relationships with and provide Quality oversight of key partner groups that are commensurately expanding in size and scope of work.
• Participate in a growing team of professionals enabling an expanding site asset base.

Associate Director, Quality Assurance

will be responsible for quality leadership and subject matter expertise in Quality Operations, Facilities and Validation, and Low Bioburden facilities at our company Rahway, New Jersey site. This position will serve an important role in supporting the expansion of clinical development activities at the site with responsibilities including, but not limited to the following:

• Execute GMP quality assurance activities directly related to facilities, equipment, and automation for clinical trial material supply capabilities.
• Support the design phases and operational readiness of one or more cross-modality capital projects that are aligned with the expanding site mission.
• Drive quality from design through qualification, start-up, and operations of new facilities as well as maintain and sustain existing operations and facilities.
• Develop relationships with and provide Quality oversight of key partner groups that are commensurately expanding in size and scope of work.
• Participate in a growing team of professionals enabling an expanding site asset base.

The successful candidate will assure that quality systems and controls for investigational new drugs (investigational medicinal products) meet all relevant our company quality requirements and regulatory standards.

Essential Duties And Responsibilities

• Manage projects and tasks affiliated with Quality oversight of GMP facilities.
• Lead and perform quality assurance activities related to qualification and validation of facility, equipment, and automation assets in a complex and rapidly changing clinical development environment. Assure compliance with cGMP, regulatory expectations, and clinical filings.
• Provide Quality oversight of GMP processes, including calibration, qualification, validation, change management, quality risk management, batch record review, and quality investigations.
• Enable the capital asset lifecycle through phases from design through start-up to deliver and sustain compliant manufacture & testing of clinical trial material.
• Build effective, collaborative working relationships and create effective communications within and across organizations.
• Identify efficiency opportunities; propose and implement value added solutions.
• Demonstrate a Quality mindset while balancing operational needs to develop pragmatic solutions to complex, technical and compliance challenges.
• Ensure current industry best practices and benchmarks are applied to design and implementation of new GMP facilities and equipment.

Education Minimum Requirement

• Bachelor’s degree in science, engineering, or related discipline; an advanced degree is preferred.

Required Experience, Knowledge, And Skills

• Minimum of 8 years of experience in Pharmaceutical / Biotechnology industry role(s). Experience in Quality, Operations, and/or related functions at pilot and/or commercial scale. Strong knowledge and application of Current Good Manufacturing Practice (cGMP). Working knowledge of capital projects and facility operations regarding the impact to health authority regulators as well as interpretation and application of GMPs. Interpersonal skills in verbal and written communications, collaboration, teamwork, negotiation, and conflict resolution.

Preferred Experience And Skills

• Leadership of cross-functional teams and problem-solving situations. Technical knowledge or proficiency in one or more elements of validation, facilities, equipment, utilities, automation, systems, unit operations in various product modalities, or associated technologies. A combination of experiences foundational to knowledge of validation - in product or process development, engineering, scale-up, manufacturing, technical operations, technology transfer, facilities, equipment, automation, quality systems, and / or quality operations. Advanced ability to identify and solve complex problems in a timely and efficient manner. Knowledge and/or experience with capital project lifecycle. Experience in R&D or clinical supply areas and processes.

Required Skills

• Compliance Investigations
• Conflict Management
• Cross-Functional Project Management
• Deviation Management
• Good Manufacturing Practices (GMP)
• Operational Quality
• Project Leadership
• Project Life Cycle Management
• Project Risk Assessments
• Quality Assurance Systems
• Quality Auditing
• Quality Management
• Quality Oversight
• Quality Risk Management
• Quality Systems Compliance
• Regulatory Compliance
• Strategic Thinking

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.

Requirements

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.

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.

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Salary Range

The salary range for this role is

$129,000.00 - $203,100.00

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.

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

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

N/A

Job Posting End Date

10/12/2026

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:R420840