QA Team Lead

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Ringaskiddy, Cork, Ireland

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Janssen Sciences is recruiting for a QA Team Lead, located in Cork-Ireland

As a QA Team Lead you will:

Lead compliance activities and QA operational activities related to Janssen Sciences Ireland (JSI) UC as per cGood Manufacturing Practice (cGMP). These activities include executive roles in leading change control, non-conformance investigations, compliance auditing, and other related quality system elements.

The responsibilities and the impact YOU will have: 

• Provides leadership and direction to the site QA and functional teams 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.
• 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 to provide oversight of qualification and validation programs.
• To review and ensure their team interpersonal capabilities, personnel proficiencies and that the number of qualified personnel continuously matches expertise and workload needed.
• Supports the Site Quality Head, Quality Director and Quality Managers in mentoring the quality team to ensure professional and personal development of department personnel.
• Partners with other Departments to ensure that compliance programs are completed in an effective manner.
• 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.
• Leads the QA team 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.
• Leading the QA team in the development and implementation of systems and procedures for the GMP qualification of suppliers and contractors to JSI. Maintains records of qualification activities in accordance with GMP.
• Coordinates QA/QS 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 JSI.
• Assists the Site Quality Head, Quality Director and QA Managers in the management of quality inspections and audits of JSI by external parties/agencies. Leads for the tracking of commitments arising from audits and communication of information to site management.
• Deputizes for the QA Manager where appropriate.
• Coordinates the activities of the group within quality to build a collaborative approach to goals and tasks.
• Through personal expertise, leadership and dedication, provides direction to the site in the development of a culture of quality and compliance.
• Domestic and international travel may be required but limited.

Key Proficiencies Required:

• Excellent social skills.
• Ability to operate as part of a team is essential.
• Innovative.
• Excellent interpersonal skills both written and verbal.
• Attention to detail.
• Good problem-solving skills.
• Results and performance focused.
• Adaptable and flexible.

We would love to hear from YOU, if you have the following essential requirements:

A minimum of 5 years’ experience in a quality or compliance role within the biological and/or pharmaceutical industry.

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.

Knowledge of Manufacturing Processes, GMPs and other industry applicable regulations including those of FDA, HPRA, EMEA and other authorities.

Advanced degree (MS, MBA, PhD) preferred.

Experience in direct interactions with regulatory agencies during site inspections.

Key Individual Leader Proficiencies:

• Lead multi-functional team(s) in assigned area of responsibility as assigned by the Senior Leadership Team.
• Provide support for the site leadership team in the development of a culture of GMP compliance at JSI.
• 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 JSI affiliates so that compliance activities are well understood and coordinated.
• Actively promote continuous compliance improvement programs.
• Represent JSI where appropriate in meetings and other communications with regulatory authorities, industry meetings, etc.
• Demonstrate CREDO value of integrity.
• Actively promote and apply critical thinking to compliance activities.
• Develops and implements systems and metrics for ongoing measurement of quality and compliance at JSI.

Are you ready to make an impact?

If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work.

We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.

 

 

Required Skills:

 

 

Preferred Skills:

Business Savvy, Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Developing Others, Fact-Based Decision Making, Give Feedback, Human-Centered Design, Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Risk Assessments, Standard Operating Procedure (SOP), Team Management