Manager CRS Laboratory

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

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

People Leader

All Job Posting Locations:

Malvern, Pennsylvania, United States of America

Job Description:

POSITION SUMMARY:

Manages all aspects of Quality Control (QC) in the Clinical, Release, and Stability (CRS) Laboratory, in support of designated Janssen Supply Chain (JSC) sites, and in full compliance with established cGMP and JSC requirements.  Develops and implements long-term strategy, and execution of Quality Control programs.  Ensures department staff complies with all J&J, JSC and government-issued environmental, health, safety, quality and regulatory policies and guidelines, including FDA, EMEA and regulatory bodies of any applicable non-EU countries,

NATURE OF TASKS:

Manages team of people leaders and technical professionals within the QC department.  Assigns work, provides overall direction, coaches and mentors, develops capabilities and takes necessary disciplinary actions.

Responsible for overseeing and managing processes for;

Ensuring adequate training (skills-based, cGMP and safety) of management and associates within the department.

Raw material, in-process, environmental/utility, product release, and stability testing.

Investigation of laboratory non-conformances (events, deviations, and invalid assays).

Maintenance, calibration and qualification of laboratory instruments and equipment.

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

Process Performance Qualification and Continued Process Verification activities associated with QC laboratory testing.

Material evaluation/testing as part of the Supplier Material Qualification (SMQ) process.

Provides expertise in troubleshooting complex laboratory issues and demonstrates strong reasoning skills in support of ongoing laboratory investigations.

Maintains detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on-the-job training requirements.

Collaborates with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.

Contributes to global strategies related to QC laboratories which align with compliance and business objects as well as the overall J&J vision.

Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA.  Complies with all company and site policies and procedures.

Manages departmental budget and resources; prepares staffing plans.  Makes adjustments to roles and responsibilities of department to meet business needs.

Reviews and/or approves 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.

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

Escalates potential product quality issues.

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

Provides oversight for raw material reduced testing programs.

Supports the Janssen Biotherapeutics Discovery and Supply (BTDS) group through;

Characterization and/or release testing for projects related to early development, clinical, and commercial products.

Co-validation and/or transfer of new analytical test methods.

Testing of Master, Working, and QC cell banks produced by the Janssen Cell Banking Center of Excellence (CoE).

Provides input to