Manager Quality Control

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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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 a Manager Quality Control

The primary responsibility of this position is to ensure that all the QC laboratories provide a compliant timely and cost-effective quality control service during the plant qualification phase and during routine plant operations. The main services provided by Quality Control are the testing of samples review and approval of results and ensuring the quality of the following: raw materials in process and final bulk materials as well as providing environmental utility and ongoing project support.

The position requires managing any of the following laboratories; In-Process Chemistry Microbiology Biochemistry and/or Bioassay laboratories in order to deliver these services along with other agreed functional goals while maintaining an environment of continuous improvement customer focus and awareness of business needs. The candidate will also be responsible for the coaching development and performance review of the QC team.

The responsibilities and the impact YOU will have:

• Ensures the team reliably deliver all batch release testing requirements.

The timely and compliant qualification of QC Analytical Equipment and Systems QC Analyst Method and Equipment Training.

Approval of all required GMP documentation related to Analytical Method Transfer.

• Timely completion of the Analytical Method Transfer process.
• Ensures operational readiness for QC laboratories during project and routine phase.

• Manages the lab team to provide compliant timely and cost-effective QC support to the plant.

• Manages the teams budget - human resources overheads and capital expenditure.

• Defines Quality Control Policies in consultation with QA and corporate guidelines.

• Anticipates and plans for future requirements in the area including such aspects as procedural requirements capital planning personnel recruitment planning compliance requirements efficiency developments and anticipated changes needed to reflect future demand for services.

• Ensures systems are in place to ensure QC activities are carried out in compliance with product license commitments cGMP and company Quality standards and guidelines.

• Identifies and implements efficiencies cost reduction quality and service level improvements.

• Ensure personnel safety is monitored by including same in departmental responsibilities ensuring adherence to relevant health & safety policies and requirements.

• Proposes and agrees with the functional goals for the area and providing timely routine reports to quality and plant management to demonstrate the current performance of the area

• Fosters a process-driven environment both within QC and with other Departments such that resources are employed efficiently and effectively.

Promotes a continuous improvement culture and providing leadership in this area.

Responsible for developing people and technical skills to implement new technologies and apply best practice. Establishes effective partnerships with other individuals departments cross-functional teams and JSC affiliates so that QC activities are well understood and coordinated.

Represents JJIM where appropriate in meetings and other communications with regulatory authorities industry meetings etc.

Facilitate an environment of continuous improvement:

To provide leadership and a clearly identifiable work ethos

Collaboration and teamwork

Ensure personal goals & objectives are completed timely and effectively

Strategic Thinker

Talent Development

Credo value of integrity

To work as a strategic partner with all other departments within the company

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

QUALIFICATIONS AND EXPERIENCE:

ESSENTIAL:

BSc in a scientific/technical discipline required.

A minimum of 10 years experience within the biological and/or pharmaceutical industry.

5 years of QC laboratory supervisory/management experience preferred.

Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.

Demonstrated knowledge and application of industry regulations as they apply to QC methods and procedures including those of FDA HPRA EMEA and other authorities.

DESIRABLE:

A minimum of a masters degree in engineering Science or equivalent technical discipline is desirable.

KEY COMPETENCIES REQUIRED:

• Excellent interpersonal skills
• Ability to operate as part of a team is critical.
• Customer focus
• Innovative
• Excellent communication skills both written and verbal
• Attention to detail
• Good problem solving skills
• Results and performance driven
• Adaptable and flexible
• Tact and diplomacy
• Confidentiality

KEY INDIVIDUAL LEADER COMPETENCIES:

• Undefined
• Thinks strategically to create growth.
• Translates vision and strategy for direct reports and team members into actionable goals and priorities.
• Takes action and makes decisions that successfully build customer value.
• Works to help others to builds strong productive relationships.
• Rewards direct reports and others for cultivating strong business relationships with people from other areas of the organization.
• Demonstrates ability to lead teams through change or transformation.
• Takes risks to drive innovation.
• Directs and encourages others to achieve innovative results.
• Demonstrates ability to work with teams and individuals.
• Asserts personal ideas and opinions using persuasion to influence others.
• Seeks opportunities to grow and develop professionally.
• Uses best practices to improve business operations.
• Holds self accountable for compliant and flawless execution.
• Takes personal responsibility for decisions that successfully build customer value.
• Effectively manages and adapts to change.
• Demonstrates the courage to stand alone on ideas and opinions that differ from others.
• Listens effectively and remains open to others ideas.
• Works effectively with people that have diverse styles talents and ideas.
• Maintains the highest standards of ethical behaviour.
• Treats people with dignity and respect.

Significant Safety or Working Considerations:

All employees are required to comply with the requirements of the companys Environmental Health & Safety Policy Safety Statement associated EHS Procedures local legislation and duties outlined in the site EHS Manual.

In line with the Safety Health & Welfare at Work Act (2005) all employees are required to:

• Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions.
• Comply with EHS rules and procedures at all times.
• Understand the potential EHS impact of their activities.
• Attend and participate in EHS training as required.
• Use PPE and safety equipment as required.
• Report all incidents accidents and near miss events.
• Report unsafe plant equipment acts procedures or issues.
• Make suggestions to improve health and safety in the workplace.
• Actively participate in work area EHS teams.
• Not turn a blind eye to unsafe acts or situations.
• Demonstrates an understanding of AI concepts and frameworks including awareness of responsible and ethical AI practices and has experience generating effective prompts to boost efficiency and productivity.

IMPORTANT

This position description is a general guideline for colleagues; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time or to vary the duties and responsibilities of the position to meet production scheduling or other business needs.

#SCQuality

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is:

Benefits:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.