Director - QA Operations

Merck • Wilmington, DE

3d • Hybrid

About The Position

The Quality Assurance Operations (QA Ops) Lead role will involve establishing the Quality structure at the Wilmington Biotech Campus, ensuring the processes conform to our company's policies and comply with cGMPs, Health Agency regulations and all other applicable governing regulations, with the mission and ambition to manufacture breakthrough medicines from Ireland for patients around the world.
Close collaboration with high performance talent from our company's global team and the biotechnology industry to develop and execute multiple Quality Assurance systems and processes will be key, and the successful candidate will inspire his/her team to build the future of the company’s antibody drug conjugates and high potent compounds through a Quality culture that delivers unconstrained supply, that is Right First Time to patients worldwide.
Providing training and guidance on the interpretation and implementation of our company's policies and regulatory requirements will also be key priorities for the Director. Throughout the development of the new facility, the successful candidate will focus on commissioning, qualification, and/or validation of the facility, equipment, and process.

Requirements

• This role requires a seasoned Director with a minimum of 15 years’ experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations.
• A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
• 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, the successful candidate will also ideally have a proven track record in delivering excellence. The candidate will also show ambition and drive to develop and advance their career within our company.

Nice To Haves

• Capital Project experience preferred.

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.

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

What This Job Offers

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