The Johnson & Johnson Family of Companies makes a big difference in the health and well-being of people every day. We have more than 250 operating companies in 57 countries employing approximately 114,000 people. Our consumer products and medical devices and diagnostics impact the state of health care for patients, doctors, and nurses around the world.
Currently for our Biopharma Organization, we are looking for highly motivated candidate for the position of:
Director of Quality control
The Quality Control department is responsible for testing of the
Company’s products and for the monitoring of critical utilities and controlled
environments within our production facilities.
As a member of the site quality leadership team you will be expected to provide proactive support to the Head of Site Quality and the Site General Manager in improving the organizational capabilities and processes of the site organization and be willing to work on regional / global projects in support of the supply chain network.
The role provides an excellent opportunity for further career and technical development within Johnson and Johnson.
- Responsibility for release testing of raw materials, commercial and clinical process intermediates and commercial drug substances.
- Responsibility for all activities related to NPI to the labs.
- Responsibility for Analytical
Equipment Lifecycle management for the Cork Bio (QC and CRS) and Cork Chem
- Manage Site Quality Control testing and release lead times to ensure timely product disposition.
- Ensure compliance to regulatory requirements
- Ensure Safety and Quality standards are reliably maintained and comply with J&J global guidelines and regulatory expectation.
- Ensure appropriately trained resources are deployed.
- Budget responsibility for Site Quality Control: CAPEX, headcount and expenses.
- Responsibility for performance and development of all Site Quality Control associates.
- Drive continuous improvement.
- Lead proactive succession planning and a high performance culture through people training and development, targeted assignments and career planning.
- Engage in sector/corporate initiatives.
- Member of the Quality Site leadership team and Site leadership team. Member of the Large Molecules Hub Leadership team within One JSC Lab.
· Crucial requirements for candidates:
Education & experience
- A minimum of a master’s degree in Engineering, Science or equivalent technical discipline is required
- A minimum of 10 years of experience in Quality related to manufacturing is required.
- Proven cycles of success with people management and leadership experience is required.
- Experience working with Quality systems is required.
- Experience with quality support in clinical manufacture or NPI is preferred.
- Extensive knowledge of chemical, biochemical and microbiological concepts is required.
- Ability to apply basic and advanced mathematical concepts (including statistics) in the evaluation of laboratory data is required.
- Knowledge of cGMP regulations and FDA/EU guidance is required.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
- Comfortable with speaking and interacting with inspectors.
- Good written and verbal communication skills in English are required.
- This position may require up to 10% domestic or international travel as business demands.
This position requires
- Strong partnering and negotiating with multiple internal, and frequently also external stakeholders.
- Demonstrated leadership skills and achievements in health care manufacturing industry with leadership responsibility in a significant laboratory function.
- A strong scientific leader with a clear understanding of regulatory expectations.
- Ability to hire, develop and retain top talent for QC operations.
- Exposure to an international working environment in previous roles is preferred.
- Regulatory and inspection experience is preferred.
- Broad business acumen, including insight in End-to-End supply chain characteristics is preferred.
- Capability of leading multiple projects at the same time.
- Track record in leading cross-functional teams.
- Ability to work across organizational boundaries through influence, negotiation and partnering for changes requiring buy-in from all partners. Ability to interact with all levels in the organization.
In return, we offer:
- An opportunity to be part of a Global market leader.
- A dynamic and inspiring working environment.
- Many opportunities to work on challenging projects and assignments.
- Opportunities for personal and professional development.
- Many employee benefits.
- We are an Equal opportunities employer.
Janssen R&D Ireland (7566)