Director, Quality Assurance – New Modalities, Antibody Drug Conjugate

MSD

Director of Quality Assurance overseeing quality for Antibody Drug Conjugates in pharmaceutical industry. Leading compliance efforts and quality management systems for new modalities pipeline products.

Posted 5/14/2026full-timeRemote • New Jersey, Pennsylvania • 🇺🇸 United StatesLead💰 $173,200 - $272,600 per yearWebsite

About the role

Key responsibilities & impact

Provide Quality leadership as part of the New Modalities Quality team to ensure end to end quality oversight necessary to facilitate agility and speed-to-market while sustaining compliant supply of new modalities pipeline products to global markets.
Stay ahead of current GMP requirements and industry trends as described in worldwide regulations and industry standards, and trend reporting.
Maintain a subject matter expert level of knowledge related to these specialized areas of expertise, with a specific focus on Antibody Drug Conjugates.
Provide guidance and coaching to manufacturing colleagues on new modalities quality oversight requirements and Health Authority GMP expectations.
Evaluate current company and partner Quality Management Systems for seamless integration and realize synergies where available while ensuring compliance to GMP requirements.
Ensure alignment to corporate policies as well as other divisional policies related to management of product quality.
Implement a fit-for-purpose QMS, ensuring end-to-end quality oversight of new modalities products manufactured at our company and external partner sites.
Partner with our company's Manufacturing Division QMS team for QMS updates as needed.
Work in partnership across the organization (Research, Manufacturing and Commercial) to understand the unique requirements for the new modality products and ensure that these requirements are addressed via fit-for-purpose quality management oversight.
Evaluate external partner Quality and compliance robustness and identify Quality risks.
Work with internal colleagues and external partners to remediate risks as appropriate.
Ensure that facilities/processes are compliant and support approval of new modality regulatory filings.
Maintain close working relationship with our research and manufacturing divisions' Quality departments and Technical CMC teams for end-to-end Quality oversight/support of new modalities products.
Support development of and report quality metrics measuring operational effectiveness to appropriate research and manufacturing divisions' governance forums.
Ensure continuous improvement to new modalities QMS to maintain GMP and Regulatory compliance.

Requirements

What you’ll need

Bachelor’s degree in Life Science Field, Engineering field or a related relevant discipline.
Minimum of ten (10) years’ experience within the pharmaceutical industry.
Experience working with or directly supporting manufacture of Antibody Drug Conjugate (ADC) products.
People change management experience
Quality operations and/or compliance experience
Demonstrated effective leadership, communication, interpersonal and negotiating skills, in particular with cross functional partners.
Ability to learn and understand technical aspects of new processes to ensure robust Quality oversight.

Benefits

Comp & perks

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Quality Management SystemsGMP complianceAntibody Drug ConjugatesQuality oversightQuality metricsRegulatory complianceOperational effectivenessChange managementRisk assessment

Soft Skills

LeadershipCommunicationInterpersonal skillsNegotiationCoachingCollaborationContinuous improvementAgilityProblem-solving