Associate Director, Quality Assurance

Job Description

Join us as the Quality Center of Excellence Lead at our Wilmington Biotech site, where you'll shape the future of breakthrough medicines by ensuring top-tier quality and compliance with global regulations. Lead a high-performance team, drive commissioning and validation excellence, and collaborate globally to deliver life-changing therapies right first time to patients worldwide. If you have 10+ years in Quality Assurance and a passion for innovation and leadership, this is your opportunity to make a global impact.

JOB DESCRIPTION & SPECIFIC OBJECTIVES

• The Quality Center of Excellence (COE) Lead role will involve establishing the Quality COE structure at the Wilmington Biotech site, ensuring the processes conform to the company 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 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 policies and regulatory requirements will also be key priorities for the Associate 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 COE Lead will:

• Be responsible for the quality aspects of commissioning, qualification, and validation of facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations. 

• Be involved in all quality-related activities for commissioning, qualification, and validation which are required by our Manufacturing Division Quality Manual or with potential for impact on product quality, patient safety or data integrity. 

• Will work closely with stakeholders and SME’s from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight throughout the qualification and validation process and facilitate continuous improvement.

• Will work on all aspects of the project through URS, FAT, SAT, IC, OC, IQ, OQ, PPQ, and commercialization

• Will serve as the Quality SME for all validation and ongoing qualification activities across the site including but not limited to: cleaning validation, utilities performance qualification, equipment requalification, new equipment installation.

• Be responsible for the quality aspects of receipt and release of incoming materials for the site.

• Be involved in all quality-related activities for the warehouse and dispensary which are required by our Manufacturing Division Quality Manual or with potential for impact on product quality, patient safety or data integrity. 

• Will ensure the site Supplier Quality Management process is established and maintained at the site. 

• Will provide quality oversight of the Lab on site and will ensure the Lab operates to our Manufacturing Division Quality Manual requirements.

• Will understand manufacturing process to ensure equipment and facility are compliant with process needs and regulatory expectations.

• Inspire and motivate his / her team to uphold a high-performance culture that drives Quality Assurance excellence.

REPORTING STRUCTURE

This position will report into the Site Quality Lead

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-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 experience in commissioning, qualification, and validation activities in in a regulated environment.

• Must have 2 years of experience in a commercial QC Lab.