Senior Manager Quality Control

Senior Manager Quality Control – 2406205418W

Description

Johnson & Johnson is currently seeking a Senior Manager Quality Control to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson, North Carolina.

While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both design & construction. For the project design phase, the role will require you to be present with our design teams in the Greater Philadelphia region. Once the design phase is completed, this role will support the construction and operational start-up of the site. For this, you will be required to be on site in Wilson, NC. Based on your current location the hiring team will work with you to determine travel and relocation arrangements. In steady state, we expect travel to be less than 10%.

J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J’s significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.

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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

Are you a seasoned professional with a passion for quality control in the biopharmaceutical industry? Do you thrive on ensuring strict compliance with regulatory standards and driving continuous improvement in laboratory operations? If so, we have an exciting opportunity for you to join our team as the Quality Control Senior Manager at our new Large Molecule Drug Substance Manufacturing facility!

In this position, you will play a crucial role in ensuring the safety, efficacy, and compliance of our products through effective management and oversight of our QC laboratories while leading a team of skilled people leaders and technical professionals, driving their professional growth, and creating a culture of excellence. Your leadership will be instrumental in delivering and maintaining our laboratorys compliance, right-first-time execution, and operational efficiency.

Essential Job Duties and Responsibilities:

Manage all aspects of the Quality Control (QC) laboratories in full compliance with established GMP and safety regulations as well as all company/site policies and procedures.

Responsible for overseeing and managing processes for;

o Training (skills-based, GMP and safety) of supervisors and associates within the department.

o Raw material, in-process, environmental/utility, microbiological and biotherapeutic drug substance release testing.

o Investigation of laboratory non-conformances and development of effective CAPAs for identified root causes.

o Maintenance, calibration and qualification of laboratory instruments and equipment.

o Qualification and administration of electronic laboratory systems.

o Test method verification, qualification, co-validation and/or transfer activities in the QC laboratories.

o Troubleshooting complex laboratory issues.

Responsible for hiring, managing, leading, and motivating the QC department personnel; including mentoring, training, and career development.

Review and/or approve quality documents (standard operating procedures, specifications, test methods, work instructions, risk assessments, technical/validation protocols and reports, etc.), non-conformance investigations, CAPA, and change controls associated with the QC laboratories.

Support internal and external audits, including external contract laboratories and GMP service providers, where required.

Analyze laboratory performance and quality data for quarterly site management and annual product reviews.

Utilize statistical tools and data analysis techniques to identify trends, monitor quality metrics, and drive continuous improvement initiatives.

Preparation of the annual Quality Control department budget and long-range financial plan for laboratory capital investments.

Stay abreast of industry advancements and changes in regulatory guidelines and requirements, and proactively implement necessary updates to the laboratorys quality control practices.

Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering, Maintenance, Value Chain/Product Quality Management and Regulatory Affairs to support business needs.

Partner with QC Leaders at other J&J sites to contribute to global strategies and to ensure harmonization and alignment with J&J Quality Policies, Procedures, Programs and Systems.

Drive a culture of quality throughout the organization, promoting a proactive approach to quality management and fostering a continuous improvement mindset.

Qualifications

Required:

A minimum of Bachelors degree in Chemistry, Biochemistry, or a related field

A minimum of 8 years’ experience working within the biological and/or pharmaceutical industry.

A minimum of 5 years’ experience working in QC supervisory/management roles.

Deep understanding and experience in application of global GMP regulatory requirements (FDA, EMA, etc.) and industry guidelines in a biological or pharmaceutical manufacturing environment.

Experience interacting with health authorities and taking a leading role in regulatory inspections and audits.

Proficient in utilizing quality control and statistical tools for data analysis and process improvement.

Detailed knowledge of financial concepts and terminology associated with capital project/budget responsibilities of the position.

Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate complex quality concepts to stakeholders at all levels.

Strong leadership skills with the ability to inspire and motivate a team of professionals.

Strong analytical and problem-solving skills, with a track record in leading investigations and implementing effective CAPAs.

Proven ability to manage multiple priorities and work independently with minimal supervision.

Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements.

Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment.

Ability to build and nurture strong and positive relationships.

The ability to work in a team environment and interact with all levels of the organization.

Results-driven leader who commits to stretch goals and delivers results.

An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.

Proven success as a people leader.

Preferred:

Masters degree in Chemistry, Biochemistry, or a related field

Experience in a supporting functional area (e.g., Manufacturing, Technical Operations, Engineering & Maintenance, R&D, etc.)

This job posting is anticipated to close on 10/20/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

Vacation – up to 120 hours per calendar year

Sick time – up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

Holiday pay, including Floating Holidays – up to 13 days per calendar year

Work, Personal and Family Time – up to 40 hours per calendar year

Additional information can be found through the link below.

For additional general information on Company benefits, please go to: – https://www.careers.jnj.com/employee-benefits

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 .

Primary Location NA-US-North Carolina-Wilson

Other Locations NA-US-North Carolina-Raleigh, NA-US-North Carolina-Goldsboro, NA-US-Pennsylvania-Horsham, NA-US-Pennsylvania-Philadelphia, NA-US-North Carolina-Greenville, NA-US-North Carolina-Rocky Mount

Organization Janssen Biotech, Inc. (6014)

Relocation Eligible: Yes – Within Country

Job Function Quality Control

Req ID: 2406205418W