Merck · 3 hours ago
Director - QA Operations
USA - Delaware - Wilmington (Biotech)
Full-time
Onsite
Director/Executive
$173K/yr - $273K/yr
15+ years expMerck is a leading global biopharmaceutical company, and they are seeking a Director of QA Operations to establish the Quality structure at their Wilmington Biotech Campus. This role involves ensuring compliance with cGMPs and regulatory requirements while leading a team to develop Quality Assurance systems and processes for the manufacturing of biologics.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
Acting in the role of leading the Quality Assurance Operations team supporting drug substance and drug product manufacturing
Responsible for ensuring that the processes for the manufacture of biologics have been conducted in compliance with GMP, the registered marketing authorization and the associated regulatory requirements
In-depth knowledge of US and European GMP guidelines, ICH and other international regulatory requirements, as applicable to the site
Drive compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements
Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations
Assisting in, and facilitating investigations, ensuring effective Root Cause Analysis and CAPAs
Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site
Be an advocate of continuous improvement in the Quality Management Systems
Provide Quality oversight to the qualification/validation, technical transfers, regulatory approvals and commercial operations at the facility
Responsible for the management of batch record review, discrepancy reporting, investigations and CAPAs associated with Drug Substance Release
Drives opportunities for continuous improvement
Provide direct audit support and participate in response team for audits and inspections by Health Authorities
Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions
Qualification
Required
A minimum of 15 years' experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations
Must have at least 3 years of operational experience in a regulated environment
Must have experience in supporting tech transfer or process validation either internally or externally
Must have 5 years' experience in Antibody Drug Conjugate Process Development and/or Manufacturing
Demonstrated knowledge of Cleaning in Place, Cleaning out of Place, Sanitize in Place
Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc)
Exceptional analytical, problem solving & root-cause analysis skills
Ability to multi-task and handle tasks with competing priorities effectively
Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & experience interfacing with regulators is preferred
Strong operations support background ensuring value added and effective quality oversight
A great communicator, decisive decision maker and proven ability to deliver excellence
Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends related to Antibody Drug Conjugate Manufacturing
Experience with new product introductions and/or process qualification/technology transfer
Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc
Excellent communication skills (written and oral)
Required to work on his/her own initiative in addition to working as part of and leading a team. Must be able to work across a team matrix in order to meet accelerated timelines
Desire to continuously learn, improve and develop
Ability to facilitate groups with diverse perspectives, and influence and bring teams to consensus and alignment
Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner
Able to demonstrate good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions; communicates influences and escalates issues and decisions as needed
Planning and scheduling skills, Proven organizational skills, Flexible approach
Goal/results orientated, Starter/Finisher
Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or in a relevant discipline
Preferred
Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & experience interfacing with regulators
Capital Project experience
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
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
2026-01-24
The Motley Fool
2026-01-24
2026-01-23
Company data provided by crunchbase