Johnson & Johnson Careers
QA Team Lead (Mat Backfill)
Requisition ID: 1805661528W
Role: QA Team Lead (Maternity Backfill) 9-12 months
Location: Ringaskiddy Cork, Ireland
Reports to: QA Manager
Janssen Sciences Ireland UC established its operation in Ringaskiddy in 2005 on a 100 acre site with an investment of €500 million. For more than 25 years we have been a global leader in the field of biomedicines, in particular pioneering monoclonal antibody technology a cutting-edge approach to producing medicines that launched a new generation of products to treat immune related diseases such as rheumatoid arthritis and plaque psoriasis.
The facility in Ringaskiddy is operational producing biomedicines for both the treatment of immune related diseases and new and innovative cancer treatments.
In 2017, Janssen Sciences Ireland UC announced that it is to invest more than €300 million in the expansion of its manufacturing plant that will create more than 200 new jobs.
A QA Team Leader is responsible for managing compliance activities and QA operational activities related to JSCI as required by Good Manufacturing Practice (GMP). These activities include executive roles in managing change control, non-conformance investigations, compliance auditing, and other related quality system elements.
What you’re great at:
A great QA Team Lead will provide leadership and direction to the site management team in respect of specific quality system and or quality operation elements to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behavior model.
As a QA Team Lead, your typical day may include:
To be part of this high performing team you will have great attention to detail, and:
•Support GMP qualification and validation activities through execution of supplier/contractor audits and directing review of qualification/validation documents to provide oversight of qualification and validation programs.
•Review 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 measureable and challenging goals for the group.
•Coaching and mentoring quality team to ensure professional and personal development of department personnel.
•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.
•Coordinates QA staff in the development and implementation of systems and procedures for the management of change control, 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 the management of non-conformance investigations as they apply to validation, plant operations and materials. Coordinates investigation activities to ensure root causes are identified and that corrective actions are appropriate. Tracks commitments arising from investigations.
•Coordinates QA staff in the development and implementation of systems and procedures for the GMP qualification of suppliers and contractors to JSCI. Maintains records of qualification activities 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.
•Deputises for the QA Manager as appropriate.
•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.
•Through personal expertise, leadership and commitment, provides direction to the site in the development of a culture of quality and compliance.
•Domestic and international travel may be required.
QUALIFICATIONS AND EXPERIENCE
•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.
•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.
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
•Rare in our background and experiences
•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
If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
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.
Janssen R&D Ireland (7566)