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Quality

Site Quality Head at Janssen Pharmaceutical Sciences Ireland

  • Titre Site Quality Head at Janssen Pharmaceutical Sciences Ireland
  • Fonction Quality
  • Sous-fonction Multi-Family Quality
  • Catégorie Director, Multi-Family Quality (P9)
  • Lieu Cork, Ireland
  • Date de mise en ligne
  • Référence 2406184681W
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Description

Site Quality Head at Janssen Pharmaceutical Sciences Ireland

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 responsibility:

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 Quality Head reports to the Vice President Supply Chain Quality, Small

Molecule. The following roles report to the Site Quality Head of JPSUC:

  • Senior Manager Quality Control
  • Qualified Person
  • Quality Assurance Team Lead

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 J&J Standard of Leadership behavior model.
  • Partners with other 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 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 small molecule 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.
  • 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.

Authority

The Site Quality Head of JPSUC is the senior manager on site with the authority to make decisions in the following areas:

  • Disposition of all raw materials, intermediates and API’s.
  • Product Recall.
  • Approval of policies with regard to products and compliance.
  • Decisions with respect to Quality and Compliance.
  • Reporting the Performance of the Quality System.

The Site Quality Head of JPSUC also has the authority to carry out functions associated with the duties listed above.

Qualifications

Essential qualifications

  • 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. R&D, 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

Key individual contributor competencies:

  • Leadership responsibilities are fulfilled through:
    • Facilitation of an environment of continuous improvement.
    • Providing leadership and a clearly identifiable work ethos.
    • Collaboration and teamwork.
    • Ensuring PC&D completed timely and effectively, and timely feedback is given to department staff in relation to individual performance.
    • Strategic thinking.
    • Talent Development.
    • Embodying a Credo value of integrity.
    • Working as a strategic partner with all other departments within the company.

In line with the Johnson & Johnson Leadership Imperatives the following leadership competencies have been identified for the position of Site Quality Head of JPSUC:

  • Serve as a role model for making Credo-based decisions, helping others understand the value of Credo-based decisions.
  • Support the creation of a trusting, collaborative, and ethical work environment that positively contributes to employee engagement.
  • Maintains the highest standards of ethics, quality, compliance and accountability; acts in accordance with the Quality & Compliance Johnson & Johnson requires; and helps others do the same when there is an opportunity.
  • Maintains awareness of the external environment, adding value and insights. Uses insights to uncover important unmet needs and encourage and support internal collaboration across levels, creating effective solutions.
  • Contributes to innovative and viable products, services and/or solutions, adding value. Challenges the status quo and adapts to change, taking advantage of opportunities to have a positive impact.
  • Identifies and communicates meaningful risks, takes appropriate action and demonstrates an awareness of the highest standards of quality and compliance.
  • Takes accountability for their performance and development alongside supporting talent acquisition and the development of others.
  • Leverages diverse perspectives, backgrounds and talent to generate effective ideas or solutions and engage in transparent and constructive conversations, contributing to high-performance teams.
  • Acts with speed, flexibility, and accountability to achieve goals. Understands how own work impacts the enterprise and uses understanding to make effective decisions and take actions and manage priorities effectively to deliver expected results

 

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.

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