Assoc. Dir, Quality Assurance

Merck • Rahway, NJ

1d • $129,000 - $203,100 • Hybrid

About The Position

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.

Requirements

• Bachelor’s degree in science, engineering, or related discipline
• 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.
• 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

Nice To Haves

• 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.

Responsibilities

• 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.
• 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.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Director