Senior Specialist Quality Assurance (COE)

Job Description

Job Description:

The Quality Center of Excellence (COE) Senior Specialist role will be involved in providing support for the Quality COE structure, ensuring the processes conform to our 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 Company global team and the biotechnology industry to develop and execute multiple Quality Assurance systems and processes will be key, and the successful candidate will be a an individual and team member the future of our Company antibody drug conjugates and high potent compounds through a Quality culture that delivers unconstrained supply, that is Right First Time to patients worldwide.

As necessary and when applicable, provide training and guidance on the interpretation and implementation of our Company policies and regulatory requirements will also be key priorities for the Senior Specialist. 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:

• •Be responsible for the quality aspects of commissioning, qualification, and validation of facilities, utilities, manufacturing, packaging, labelling, and laboratories to ensure compliance with company policies, procedures, and regulatory expectations.
• •Participate in quality-related activities for commissioning, qualification, and validation which are required by the Manufacturing Division Quality Manual or with potential for impact on product quality, patient safety, or data integrity.
• •Collaborate closely with stakeholders and SMEs from site operations, quality operations, IT, automation, and engineering to provide evidence of quality input throughout the qualification and validation process and facilitate continuous improvement.
• •Work on aspects of the project through URS, FAT, SAT, IC, OC, IQ, OQ, PPQ, and commercialization.
• •Serve as the Quality contact for validation and ongoing qualification activities across the site including, but not limited to cleaning validation, utilities performance qualification, process validation, equipment requalification, new equipment installation.
• •Provide quality oversight of the Lab on site and will ensure the Lab operates to Manufacturing Division Quality Manual requirements.
• •Help support and maintain the Supplier Quality Management (SQM) process at the site.
• •Understanding of the manufacturing process to ensure the equipment and facility are compliant with process needs and regulatory expectations.
• •Knowledge of US and European cGMP guidelines, ICH, and other international regulatory requirements, as applicable to the site.

Qualifications & Experience:

General:

• •This role requires an individual with a minimum of 5 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.

Technical:

• •Must have at least 2 years of experience in commissioning, qualification, and validation activities in in a regulated environment.
• •Must have at least 2 years of experience in a commercial QC Lab.

• •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 & demonstrated experience interfacing with regulators.
• •Strong operations support background ensuring value added and effective quality oversight.

People

• •A great communicator, decisive decision maker, and proven ability to deliver excellence.
• •Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
• •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 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.

Education

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.

#ADC

Required Skills:

Ability to Coordinate, Ability to Coordinate, Adaptability, CAPA Management, cGMP Regulations, Change Management, Cleaning Equipment, Competency Management, Continuous Development, Critical Thinking, Deviation Management, Evaluate Information, Good Automated Manufacturing Practice (GAMP), Government Regulation, Manufacturing Quality Control, Operational Quality, Pharmaceutical Quality Assurance, Prioritization, Procedure Adherence, Product Disposition, Quality Assurance Processes, Quality Auditing, Quality Compliance, Quality Management Standards, Quality Measurements {+ 10 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our col