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/.

Main Responsibilities:

This position is responsible for leading and managing all Quality related programmes and activities to support the site and manufacturing operations. These functions and activities include Quality Control testing, Quality Assurance review and approval functions, Compliance activities, Product Release activities, etc.

Reporting Relationships:

The Site Head of Quality reports to the Vice President Supply Chain Quality, Large Molecule. The following roles report to the Senior Director of Quality Janssen Sciences Ireland (JSI): QC Director, QA Manager, QS Manager, Senior Scientist, Microbiology.

Main duties and responsibilities:

Responsible for appropriately staffing and developing the Quality organization to meet business needs and succession plans. Provides leadership and direction to the Quality and Site Management Teams to ensure business, quality and compliance goals are met following the JJ Standard of Leadership behavior model. Partners with other Janssen Supply Chain (JSC) Site Quality Heads and Headquarters Quality head to ensure harmonization and alignment with JSC Quality Policies, Guidelines, Programs and Systems. Functions in a leadership role on the Site Leadership Team, lead by the Site General Manager for site operations. Ensures financial leadership by developing appropriate operating and capital expense budgets and strives to have the Quality organization contribute to Cost of Goods Sold (COGS) improvement. Supports Quality PE and Metrics Program. Provide leadership to direct reports and JSC through:Develops and champions an organizational culture that promotes behaviors that lead to superior business performance and organisational excellence.Creates a commitment to customer service.Engages in proactive relationships with the local/regional/national regulatory authority.Analyzes regulatory authorities programs and activities in areas relevant to biological products and advises site and Quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.Manages and guides staff and those involved in quality activities to achieve the best results.Mentors and coaches staff, as well as develops and implements training programs, to ensure professional and personal development of department personnel.Interfaces professionally with other departments, as well as staff from other affiliates.Function as a key member of JSC Global Quality Leadership Team.Ensures all employees comply with all applicable JSC and governmental (EPA, HSA, FDA, etc.) regulations, policies and guidelines.Management Representitive (MR) of Quality Systems Management Review (QSMR).

Other responsibilities:

Gives strategic direction to the QC, and QA groups in the execution of their duties. Works with Regulatory Affairs to ensure that the elements of the Marketing Authorisation and other filings are incorporated into site documentation and systems as appropriate.Coordinates the activities of the groups within quality to create a synergistic approach to goals and tasks.Provides coaching, mentoring, and direction to Quality Department staff as appropriate.Through personal expertise, leadership and commitment, provides direction to the site in the development of a culture of quality and compliance.Sponsors cross-functional teams towards a process driven organisational culture.Participates in the overall collective leadership by the senior management team at the site.Travels to locations in order to facilitate/coordinate activities, resolve issues, etc.

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/.

Main Responsibilities:

This position is responsible for leading and managing all Quality related programmes and activities to support the site and manufacturing operations. These functions and activities include Quality Control testing, Quality Assurance review and approval functions, Compliance activities, Product Release activities, etc.

Reporting Relationships:

The Site Head of Quality reports to the Vice President Supply Chain Quality, Large Molecule. The following roles report to the Senior Director of Quality Janssen Sciences Ireland (JSI): QC Director, QA Manager, QS Manager, Senior Scientist, Microbiology.

Main duties and responsibilities:

Responsible for appropriately staffing and developing the Quality organization to meet business needs and succession plans. Provides leadership and direction to the Quality and Site Management Teams to ensure business, quality and compliance goals are met following the JJ Standard of Leadership behavior model. Partners with other Janssen Supply Chain (JSC) Site Quality Heads and Headquarters Quality head to ensure harmonization and alignment with JSC Quality Policies, Guidelines, Programs and Systems. Functions in a leadership role on the Site Leadership Team, lead by the Site General Manager for site operations. Ensures financial leadership by developing appropriate operating and capital expense budgets and strives to have the Quality organization contribute to Cost of Goods Sold (COGS) improvement. Supports Quality PE and Metrics Program. Provide leadership to direct reports and JSC through:Develops and champions an organizational culture that promotes behaviors that lead to superior business performance and organisational excellence.Creates a commitment to customer service.Engages in proactive relationships with the local/regional/national regulatory authority.Analyzes regulatory authorities programs and activities in areas relevant to biological products and advises site and Quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.Manages and guides staff and those involved in quality activities to achieve the best results.Mentors and coaches staff, as well as develops and implements training programs, to ensure professional and personal development of department personnel.Interfaces professionally with other departments, as well as staff from other affiliates.Function as a key member of JSC Global Quality Leadership Team.Ensures all employees comply with all applicable JSC and governmental (EPA, HSA, FDA, etc.) regulations, policies and guidelines.Management Representitive (MR) of Quality Systems Management Review (QSMR).

Other responsibilities:

Gives strategic direction to the QC, and QA groups in the execution of their duties. Works with Regulatory Affairs to ensure that the elements of the Marketing Authorisation and other filings are incorporated into site documentation and systems as appropriate.Coordinates the activities of the groups within quality to create a synergistic approach to goals and tasks.Provides coaching, mentoring, and direction to Quality Department staff as appropriate.Through personal expertise, leadership and commitment, provides direction to the site in the development of a culture of quality and compliance.Sponsors cross-functional teams towards a process driven organisational culture.Participates in the overall collective leadership by the senior management team at the site.Travels to locations in order to facilitate/coordinate activities, resolve issues, etc.

Essential:

Advanced degree required in a scientific or engineering discipline.10-15 years’ experience in a significant leadership position within the biological and/or pharmaceutical industry.5 years’ experience in a Quality leadership role required.Experience Interaction with FDA/EMEA regulatory requirements applicable to biologics or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position. Proven success in managing in a global organization.

Desirable:

5 years’ experience in a supporting functional area (e.g. RD, Manufacturing, Engineering, EHS, Technical Services).

Key competencies required:

Excellent interpersonal skills. Quality management skills: problem solving, statistical thinking, design of experiments, etc. Relationship skills: negotiation skills, presentation skills, able to read the corporate culture, listening skills, harvests people’s energy, manages diverse team members. Innovative, tenacious, and passionate about quality. Time management skills. Attention to detail without losing sight of the big picture. Keeps up to date with technical and managerial developments in the industry. Results and performance driven. Adaptable and flexible.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Essential:

Advanced degree required in a scientific or engineering discipline.10-15 years’ experience in a significant leadership position within the biological and/or pharmaceutical industry.5 years’ experience in a Quality leadership role required.Experience Interaction with FDA/EMEA regulatory requirements applicable to biologics or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position. Proven success in managing in a global organization.

Desirable:

5 years’ experience in a supporting functional area (e.g. RD, Manufacturing, Engineering, EHS, Technical Services).

Key competencies required:

Excellent interpersonal skills. Quality management skills: problem solving, statistical thinking, design of experiments, etc. Relationship skills: negotiation skills, presentation skills, able to read the corporate culture, listening skills, harvests people’s energy, manages diverse team members. Innovative, tenacious, and passionate about quality. Time management skills. Attention to detail without losing sight of the big picture. Keeps up to date with technical and managerial developments in the industry. Results and performance driven. Adaptable and flexible.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.