USA - New Jersey - Rahway, United States of America
Hybrid
Job Description
The Biologics/Vaccine Development Quality (BVDQ) within Global Development Quality is responsible for technical, operational and strategic quality oversight of a growing and fast-moving large molecule pipeline. BVDQ is specifically focused on quality oversight for large molecule drug substance process & analytical development, GMP clinical manufacturing, and the testing & release of clinical supplies.
The Associate Director, Quality Assurance BVDQ is responsible for providing quality leadership and subject matter expertise in quality activities to further the analytical and process development of large molecule programs and to ensure compliance with cGMPs, applicable worldwide regulations, and our company's requirements for supported area(s).
The successful candidate ensures that quality systems and controls meet our company quality requirements and applicable regulatory standards by applying a strong Quality mindset, partnering with stakeholders, and enabling compliant decision-making across routine operations and complex events with responsibilities including, but not limited to:
Provide Quality oversight and execute GMP/GxP quality assurance activities supporting manufacturing and testing operations, including material and batch documentation review, and batch disposition.
Provide Quality oversight of an evolving biologics clinical space, including proactive risk detection and mitigation, setting strategy, and ensuring compliance in fast-paced operations areas.
Support operational readiness by partnering cross-functionally to enable compliant start-up, execution, and sustainment of GMP activities and improvements.
Drive a quality-by-design mindset by ensuring appropriate quality systems, procedures, and documentation controls are applied through planning, execution, and routine operations.
Build and maintain effective partnerships with key stakeholders to provide Quality guidance, timely decision-making, and oversight of quality events (e.g., deviations, change controls, CAPA, and audit support).
Contribute to a culture of compliance and continuous improvement by supporting training expectations, audit readiness, and quality performance monitoring/metrics.
Essential Duties and Responsibilities
Responsibilities include but are not limited to:
Serve as a Quality SME and leader by staying current on cGMP requirements, applicable worldwide regulations, and industry trends impacting large molecule analytical, process development, and manufacturing; translate requirements into clear expectations and risk-based oversight for supported programs.
Provide governance for the SOP/control document strategy within supported areas by setting standards for content, review cadence, and compliance; ensure procedures remain aligned with current regulations and department practices.
Provide strategic Quality oversight for analytical and process GMP documentation supporting regulatory filings, clinical supply development, and technology transfer by setting review priorities, ensuring consistency of position, and mentoring others through complex reviews and approvals.
Serve as Quality representation for internal and/or external manufacturing and testing by providing governance and compliance oversight of program activities, including batch record strategy and approval, and serving as the escalation point for deviation and/or out-of-specification decisions, as applicable.
Represent Quality leadership on cross-functional and project teams by applying GMP and quality standards, policies, and setting clear expectations; drive alignment across stakeholders and ensure decisions are documented, risk-based, and inspection-ready.
Provide leadership and accountable oversight for clinical release and/or re-evaluation (retest) dating decisions by ensuring a compliant, risk-based approach that meets applicable worldwide regulatory requirements and program timelines.
Own and drive delivery of key Quality oversight deliverables for large molecule drug substance analytical/process development, including establishing expectations for testing and release of clinical material and proactively managing risks, issues, and stakeholder alignment.
Provide Quality review and approval of analytical and manufacturing documents by ensuring a consistent Quality position, regulatory compliance, and alignment to our company's requirements; coach stakeholders to strengthen document quality and right-first-time execution.
Provide quality risk management support across programs by facilitating risk-based decisions with cross-functional leaders, and ensuring appropriate escalation and mitigation plans for compliance and patient safety.
Drive cross-functional analytical and process initiatives by setting Quality strategy and expectations, influencing prioritization, and ensuring outcomes remain aligned to the GMP continuum, applicable standards, and program needs.
Influence and align stakeholders through clear written and verbal communication; lead complex discussions to resolve issues, manage conflict, and enable timely, compliant, and business-informed decisions.
Champion a safety-first, quality-always culture by role modeling desired behaviors, developing others through coaching and feedback, and driving continuous improvement to strengthen inspection readiness and quality performance across supported teams.
Education Minimum Requirement:
Bachelor’s degree in science, engineering, or related discipline
Required Experience, Knowledge, and Skills:
Minimum of 8 years of experience in Pharmaceutical / Biotechnology industry role(s) with a BS, or 5+ years with an advanced degree
Strong experience in Biologics Quality, Operations, and/or related functions at pilot and/or commercial scale.
Demonstrated experience with quality risk management.
Strong knowledge and application of Current Good Manufacturing Practice (cGMP).
Strong compliance knowledge and understanding of health authority regulations, and interpretation and application of GMPs within an R&D environment (i.e., apply the GMP Continuum).
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.
Strong knowledge of biologics processes, analytical, and regulatory requirements.
Technical knowledge or proficiency in one or more elements of: GMP cleanroom facilities, electronic batch records, data integrity, SAP, automation, GMP operations in various product modalities or associated technologies.
Advanced ability to identify and solve complex problems in a timely and efficient manner.
Experience in facility start-up and GMP Operational Readiness or clinical supply areas and processes.
Required Skills:
Adaptability, Adaptability, Audit Management, Biopharmaceutical Industry, Compliance Investigations, Deviation Management, Global Program Development, GMP Compliance, Good Manufacturing Practices (GMP), Inspection Readiness, Manufacturing Support, Prioritization, Project Leadership, Project Risk Assessments, Quality Assurance Monitoring, Quality Assurance Systems, Quality Monitoring, Quality Oversight, Quality Risk Management, Quality Systems Compliance, Regulatory Compliance, Regulatory Requirements, Risk Based Approach, Risk Management and Mitigation, Strategic Thinking {+ 2 more}Preferred Skills:
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The salary range for this role is
$129,000.00 - $203,100.00This 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
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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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
NoJob Posting End Date:
06/5/2026*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.
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