Director - QA Operations

Job Description

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.

POSITION RESPONSIBILITIES

With energy and enthusiasm, the Quality Assurance Operations Lead will:

a)    Acting in the role of leading the Quality Assurance Operations team supporting drug substance and drug product manufacturing.

b)    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.

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 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 direct 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.

REPORTING STRUCTURE

This position will report into the Site Quality Lead

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

General

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.

Technical

• 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, Cle