Senior Manager Quality Control

4 days ago

Philadelphia, Pennsylvania, United States J&J Family of Companies Full time
Job Title: Senior Manager Quality Control

We are seeking a highly skilled Senior Manager Quality Control to join our team at Johnson & Johnson Innovative Medicine Supply Chain organization in Wilson, North Carolina.

About the Role:

This is a critical leadership position responsible for ensuring the safety, efficacy, and compliance of our products through effective management and oversight of our QC laboratories. The successful candidate will lead a team of skilled professionals, drive their professional growth, and create a culture of excellence.

Key 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.
  • Oversee and manage processes for training, raw material testing, environmental/utility testing, microbiological testing, biotherapeutic drug substance release testing, investigation of laboratory non-conformances, maintenance, calibration, and qualification of laboratory instruments and equipment, qualification and administration of electronic laboratory systems, test method verification, qualification, co-validation, and/or transfer activities, troubleshooting complex laboratory issues, and review and/or approval of quality documents.
  • Responsible for hiring, managing, leading, and motivating the QC department personnel, including mentoring, training, and career development.
  • 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 laboratory's 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.
Requirements:
  • A minimum of Bachelor's 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 Qualifications:
  • Master's degree in Chemistry, Biochemistry, or a related field.
  • Experience in a supporting functional area (e.g., Manufacturing, Technical Operations, Engineering & Maintenance, R&D, etc.).

We offer a competitive salary and benefits package, including 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)).

We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and experienced professional looking for a challenging role, please submit your application.

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