Role: QA Team Leader
Location: Ringaskiddy Cork, Ireland
Reports to: Quality Lead
Janssen Sciences Ireland UC, (previously Janssen Biologics), is part of the Johnson & Johnson family of companies, the world’s most comprehensive and broadly-based manufacturer of healthcare products and related services. Our site in Ringaskiddy was established in 2005 on a 100-acre site with an investment of €500 million. We manufacture a range of biopharmaceutical products indicated for the treatment of conditions that include rheumatoid arthritis, psoriasis and cancer.
We are expanding our site to allow us to meet the critical needs of patients around the world. The expansion plans involve an investmentthat which will increase the existing manufacturing space by an additional 19,100m2, provide employment for up to 450 people during construction and an extra 200 people once completed.
We have an exciting opportunity for a QA Team Leader to join our expanding team in Cork to help support this expansion.
The QA Team Leader will be responsible for the following.
Managing compliance activities and QA operational activities related to BioCork 2 project and JSCI as required by Good Manufacturing Practice (GMP). These activities include executive roles in managing commissioning and qualification, change control, non-conformance investigations, compliance auditing, and other related quality system elements.
You will have fulfilled the educational requirements for this role and have experience in a similar role within a FDA/EMEA regulated environment.
What you’re great at:
• Excellent interpersonal skills
• Ability to operate as part of a team is critical.
• Customer focus
• Excellent communication skills both written and verbal
• Attention to detail
• Good problem solving skills
• Results and performance driven
• Adaptable and flexible
• Coaching and mentoring style
• Integrity, trustworthiness and objectivity
• Knowledgeable of FDA/EMEA regulatory requirements
As a QA Team Leader, your typical day may include:
• Supports GMP qualification and validation activities through execution of supplier/contractor audits and directing review of qualification/validation documents providing oversight of qualification and validation programs.
• Reviews and ensures their team organizational capabilities, personnel competencies and that the number of qualified personnel continuously matches expertise and workload needed, to plan for future requirements in the area.
• Motivating and developing reports in addition to developing and setting measurable and challenging goals for the group.
• Partners with other Departments to ensure that compliance programs are completed in an efficient manner and are effectively maintained.
• Actively participates in management of the Quality Department through budget forecasting and preparation, training of staff, and deputizing for other members of the department management team as appropriate.
• Responsible for QA staff in the development and implementation of systems and procedures for the management of change control and deviation management, as it applies to plant installations, systems, and operations in accordance with GMP.
• Coordinates QA staff in the development and implementation of systems and procedures for external audits and inspection management suppliers and contractors and reporting to plant management on the state of compliance at JSCI. Assists Quality Director and QA Managers in management of quality inspections and audits of JSCI by external parties/agencies. Manages the tracking of commitments arising from audits and communication of information to site management on commitment completion.
• Gives direction to the QA Group in the execution of their duties.
• Coordinates the activities of the group within quality to create a synergistic approach to goals and tasks.
• Domestic and international travel may be required.
What we’re about:
We are passionate about our work, and play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We share a kind of DNA where we’re each:
• Committed to caring
• Responsible to our communities
• Ready to apply our knowledge and know-how
• The drivers of our own success
• Passionate about doing what’s right
Make a unique mark in your career
If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your real passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting www.careers.jnj.com.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.Qualifications
• A Bachelors Degree in a scientific/technical discipline required.
• A minimum of 5 years experience in a quality or compliance role within the biological and/or pharmaceutical industry.
• A minimum of 3 years management experience required.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
• Demonstrated knowledge and application of industry regulations including those of FDA, IMB, EMEA and other authorities.
• Focus on patients and customers at all times.
• Advanced degree (MS, MBA, PhD) preferred.
• Experience in direct interactions with regulatory agencies during site inspections.
• Experience in auditing of external suppliers, contractors and vendors.Primary Location
Janssen R&D Ireland (7566)Job Function
Quality AssuranceRequisition ID