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Quality

Senior Manager, Quality Control

  • Job Title Senior Manager, Quality Control
  • Function Quality
  • Sub Function Quality Control
  • Location Malvern, Pennsylvania, United States
  • Date Posted
  • Requisition Number 2206088655W
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Description

Janssen Biotech, Inc, part of the Johnson & Johnson family of companies, is hiring for a Senior Manager, Quality Control located in Malvern, Pennsylvania!

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.   Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies.

Job Summary:

Responsible for the execution of all activities under the remit of a Quality Control Lab, with the primary responsibility to ensure that the QC Lab delivers a compliant, timely and cost effective service to Malvern. Quality Control responsibilities include the testing of samples, review and approval of results and ensuring the quality of raw materials, in process and final bulk materials, as well as providing environmental, utility, and ongoing project support.

 

The QC Laboratory Manager role leads the relevant 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. This is a diverse Lab Group which provides key services to the wider QC Operations labs , the Large Molecule Quality Network as well as Malvern Operations, Springhouse CAR-T facility, Cell Banking Center of Excellence and BioTD-AD.

 

The QC Manager will play a key role leading the QC Leadership Team and will also participate as an integral part of the LMQ Laboratory framework and Site Quality Leadership team.

 

What you’re great at:

  • A leader with a passion for developing your team.

  • Practicing Servant Leadership by facilitating and empowering the individual teams to deliver QC testing services, projects or initiatives per agreed delivery timelines.

  • Ability to clearly communicate whilst ensuring understanding.

  • Developing and setting measurable and results driven goals.

  • Ability to adapt to any situation and be decisive.

  • Excellent interpersonal skills with a clear collaborative approach.

  • A Focus on Lean Operational excellence approach to Laboratory operations.

  • Strategic thinking

  • Ability to operate as a team and influence a team is critical.

  • Consistent track record in quality risk management and GMP requirements

  • Customer focus

  • Innovative

  • Keeping up to date with the regulatory, technical developments in the industry that will affect products on-site

  • Maintaining the highest standards of ethical behavior

 

The responsibilities and the impact YOU will have:

  • Owns the relevant QC Laboratories to provide compliant, timely and cost-effective QC support.

  • Approval of all required GMP documentation related to QC Lab Operations.

  • Ensures Continuous Operational readiness for QC laboratory during Project Phase, Scale up and routine Manufacturing operations.

  • Handles the QC department budget, HR and Talent objectives, Opex and Capital expenditure and Business Performance goals.

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

  • Anticipates and plans for future requirements and agility in the Labs, including such aspects as procedural requirements, capital planning, personnel recruitment planning, compliance requirements, efficiency and optimization objectives and anticipated changes needed to reflect future demand

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

  • Planning and delivery the QC digital and Technology Objectives in alignment with the Lab Strategic Objectives

  • Propose and agree the functional objectives and providing timely output to laboratory and quality management to demonstrate the current performance.

  • Promotes a continuous improvement culture and providing leadership in this area as well as Finding opportunities to improve the services provided e.g., new technologies, improved vendor processes, cost, quality etc.

  • Establishes effective partnerships with other individuals, departments, cross- functional teams and JSC affiliates so that analytical services are well understood and coordinated.

  • Represents Malvern where appropriate in meetings and other communications with regulatory authorities & industry meetings.

Qualifications

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

  • Bachelor’s degree in a scientific/technical field is required.

  • At least 8 years relevant experience within regulated biologics/ pharmaceutical industry required.

  • Minimum of 5 years in a Supervisory/Leadership role is required.

  • Knowledgeable of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals required.

  • Proven ability to lead a team to successfully deliver complex projects.

  • Ability to apply GMP regulations and other relevant international guidelines to all aspects of the position.

  • Focus on patients and customers at all times.

  • Experience with working in a global/matrix organization preferred

This is what awaits YOU at J&J:

This is an opportunity to work with a ground-breaking biomedicine operation and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement.

 

We are passionate about our work; we play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson, our culture enables dynamic and impactful careers.

Whether you’re one of the people who already work here, or you’re considering joining the team, we offer:

  • An opportunity to be part of a global market leader.

  • A dynamic and inspiring working environment.

  • Opportunities to work on challenging projects and assignments.

  • Possibilities for further personal and professional development/education

  • Excellent benefits

 

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

 

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.

 

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

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