Associate Director, Drug Product, Quality Assurance

Merck•Wilmington, DE

6d•$142,400 - $224,100•Hybrid

About The Position

The Associate Director for Drug Product Quality Assurance (DP-QA) establishes the Quality structure and ensures that processes conform to company policies and comply with cGMPs, Health Agency regulations, and other applicable requirements. The role collaborates with global colleagues and biotechnology industry talent to develop and execute Quality Assurance systems and processes, and to foster a Quality culture supporting reliable, right-first-time supply of antibody drug conjugates and high-potent compounds to patients worldwide. The position provides training and guidance on company policies and regulatory requirements. During development of the new facility, the role focuses on commissioning, qualification, and/or validation of the facility, equipment, and processes. It leads the sterile Drug Product QA team and provides Quality oversight across qualification and validation, technical transfers, regulatory approvals, and commercial operations for sterile DP. The Associate Director supports manufacturing compliance, GMP documentation review and approval, investigations and CAPAs, batch record review, discrepancy reporting, Drug Product Release, audit and inspection readiness, regulatory submissions, and continuous improvement. The role also manages shift specialists within the Drug Product QA Operations organization.

Requirements

At least 10 years of experience in Quality Control, Quality Assurance, Pharmaceutical, Vaccine or Biological Operations, or Technical Operations.
At least 5 years of operational experience in a regulated environment.
Experience supporting technology transfer or process validation, internally or externally.
Experience in Drug Product Quality Operations and batch record review.
Demonstrated knowledge of Cleaning in Place, Cleaning out of Place, and Sanitize in Place.
Understanding of continuous Quality and process improvement tools, such as DMAIC, Lean QA, or 5S.
Strong analytical, problem-solving, and root-cause analysis skills.
Ability to multitask and effectively manage competing priorities.
Strong operations-support background and ability to provide effective, value-added Quality oversight.
Knowledge of relevant cGMPs, regulations, and industry trends related to antibody drug conjugate Drug Product manufacturing.
Experience with new product introductions and/or process qualification or technology transfer.
Ability to communicate across organizational levels about design controls, design verification and validation, production and process controls, CAPA, complaints, risk management, and product quality improvement.
Excellent written and oral communication, presentation, and interpersonal skills.
Ability to work independently and guide a team, including across a matrix, to meet accelerated timelines.
Ability to facilitate groups with differing perspectives and bring teams to consensus and alignment.
Good judgment in collecting and synthesizing relevant information for timely decisions, and in communicating or escalating issues and decisions as needed.
Planning, scheduling, and organizational skills; flexible approach; goal- and results-orientation.
Bachelor’s degree or higher in Chemistry, Biology, Microbiology, Automation, Engineering, or a relevant discipline.
Self-starter with contemporary knowledge of relevant cGMPs, regulations, and industry trends.

Nice To Haves

Global regulatory experience and experience interfacing with regulators.
Direct experience in antibody drug conjugate manufacturing.
Proven track record in delivering excellence.

Responsibilities

Lead the sterile Drug Product Quality Assurance team.
Ensure biologics Drug Product manufacturing processes comply with GMP, the registered marketing authorization, and associated regulatory requirements.
Drive site compliance by ensuring adherence to divisional policies, guidelines, and regulatory requirements.
Review and approve GMP documentation supporting corporate compliance and regulatory expectations for manufacturing operations.
Assist with and facilitate investigations, ensuring effective root-cause analysis and CAPAs.
Identify and facilitate major compliance initiatives to improve site compliance status and operational efficiency.
Promote continuous improvement in Quality Management Systems and operations.
Provide Quality oversight for qualification and validation, technical transfers, regulatory approvals, and commercial operations for sterile Drug Product at the facility.
Manage batch record review, discrepancy reporting, investigations, and CAPAs associated with Drug Product Release.
Support audits and participate in response teams for Health Authority audits and inspections.
Support regulatory submission preparation and inspection readiness; participate in Health Authority inspections, interact with inspectors, respond to inspection observations, and monitor follow-up actions.
Manage shift specialists within the Drug Product QA Operations organization.
Provide training and guidance on interpreting and implementing company policies and regulatory requirements.
Focus on commissioning, qualification, and/or validation of the facility, equipment, and processes during development of the new facility.