Overview
Associate Director, QA Operations, Drug Substance Jobs in Wilmington, USA at Merck
** Job Description*
* The Associate Director for Drug Substance Quality Assurance (DS-QA) role will involve establishing the Quality structure at our 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 Delaware 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 our 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 role. Throughout the development of the new facility, the successful candidate will focus on commissioning, qualification, and/or validation of the facility, equipment, and process.
** POSITION RESPONSIBILITIES*
* With energy and enthusiasm, the Drug Substance Quality Lead will:
a) Acting in the role of leading the Drug Substance (DS) Quality Assurance team.
b) Responsible for ensuring that the processes for the manufacture of biologics DS have been conducted in compliance with GMP, the registered marketing authorisation and the associated regulatory requirements.
c) In-depth knowledge of US and European GMP guidelines, ICH and other international regulatory requirements, as applicable to the site.
d) Drive compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements.
e) Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations.
f) Assisting in, and facilitating investigations, ensuring effective Root Cause Analysis and CAPAs.
g) Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site.
h) Be an advocate of continuous improvement in the Quality Management Systems.
i) Provide Quality oversight to the qualification/validation, technical transfers, regulatory approvals and commercial operations for DS at the facility.
j) Responsible for the management of batch record review, discrepancy reporting, investigations and CAPAs associated with Drug Substance Release.
k) Drives opportunities for continuous improvement.
l) Provide audit support and participate in response team for audits and inspections by Health Authorities.
m) 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.
n) Manage team of shift specialists within the Drug Substance QA Operations organization.
** REPORTING STRUCTURE*
* This position will report into the Director-QA Operations for the site.
** QUALIFICATIONS & EXPERIENCE – KNOWLEDGE AND SKILLS REQUIREMENTS*
* ** General*
* This role requires a seasoned Associate Director with a minimum of 10 years’ experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations.
A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
The successful candidate will also ideally have a proven track record in delivering excellence.
Direct experience in manufacture of antibody drug conjugates preferred.
The candidate will also show ambition and drive to develop and advance their career within our company.
** Technical*
* + Must have at least 5 years of operational experience in a regulated environment.
+ Must have experience in supporting tech transfer or process validation either internally or externally.
+ Must have experience in drug substance quality operations and batch record review.
+ 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.
** People*
* + A great communicator…
Title: Associate Director, QA Operations, Drug Substance
Company: Merck
Location: Wilmington, USA
Category:
