Johnson & Johnson Careers
Quality Assurance Team Leader
Requisition ID: 1905762859W
QA Team Leader
This position is responsible for 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.
This Position provides leadership and direction to the site management team in respect of specific quality system and or quality operation elements to ensure project, business, quality and compliance goals are met following the J&J Standard of Leadership behavior model.
Provides leadership in the development and management of Quality through the following actions:
- 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 measureable 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.
Key competencies required:
- 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 QUALIFICATIONS AND
- 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
Key individual leader competencies:
- Provide support for the site leadership team in the development of a culture of GMP compliance at JSCI.
- Influence and facilitate the work of other departments and functions in achieving and maintaining a state of GMP compliance.
- Establish effective partnerships with other individuals, departments and JSC affiliates so that compliance activities are well understood and coordinated.
- Translates vision and strategy for direct reports and team members into actionable goals and priorities
- Works to help others to build strong productive relationships
- Rewards direct reports and others for cultivating strong business relationships with people from other areas of the organization.
- Directs and encourages others to achieve innovative results
- Asserts personal ideas and opinions using persuasion to influence others
- Represent JSCI where appropriate in meetings and other communications with regulatory authorities, industry meetings, etc.
- Demonstrate credo value of integrity
- Actively promote and apply strategic thinking to compliance activities
- Effectively manages and adapts to change
- Listens effectively and remains open to other’s ideas
Janssen R&D Ireland (7566)