Director, Quality Operations, Facilities & Validation - Hybrid

Job Description

The Director, Quality Assurance will be responsible for team leadership and subject matter expertise in Quality Operations, Facilities and Validation at the our Company's Rahway, New Jersey site. This position will serve a critical 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 multiple significant 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.

• Lead and develop 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 quality requirements and regulatory standards.

Essential Duties and Responsibilities:

• Manage people and projects 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, and quality investigations.

• Lead and 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.

• Lead people and actively foster employee development. Develop talent to evolve the workforce, to deliver and maintain an expanding GMP asset base at the Rahway site.

Education Requirement:

• Minimum education: Bachelor Degree in Scientific, Engineering, or related discipline.

• Preferred education: Advanced Degree

Required Experience, Knowledge, and Skills:

• Minimum of 12 years of experience in Pharmaceutical / Biotechnology industry role(s).

• Experience in Quality and Operations, at pilot and/or commercial scale.

• Strong knowledge and application of Current Good Manufacturing Practice (cGMP).

• Working knowledge of capital projects and facility operations.

• Leadership of people, cross-functional teams, problem-solving situations.

• Interpersonal skills in verbal and written communications, collaboration, teamwork, negotiation, and conflict resolution.

Preferred Experience and Skills:

• Advanced to Expert level leadership and people management skillsets; with experience in leading, growing, and developing people and teams.

• Advanced to Expert level technical knowledge 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.

EligibleforERP

Required Skills:

Auditing, Auditing, Capital Assets, Capital Projects, Change Management, Client Relationship Building, Clinical Development, Clinical Supplies Management, Clinical Trials, Creativity, Cross-Cultural Awareness, Diversity Programs, Facility Management, GMP Compliance, Good Manufacturing Practices (GMP), Leadership, Management Process, Mentoring Staff, People Leadership, Pharmacovigilance, Policy Implementation, Process Improvements, Quality Assurance Processes, Quality Assurance Review, Quality Assurance Systems {+ 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 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

$173,200.00 - $272,600.00

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

No

Job Posting End Date:

03/19/2026

*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.