Mgr Quality Control

Location: Malvern

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 Med Tech, 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.

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Job Function:
Quality

Job Sub Function:
Quality Control

Job Category:
People Leader

All Job Posting Locations:
Malvern, Pennsylvania, United States of America

Job Description:

General Information

Position Title:

Manager Quality Control

Department Name:

Quality Operations

Physical Location of Role:

Malvern, PA or Spring House, PA

Position Summary

Manages all aspects of Quality Control (QC), in support of designated Innovative Medicine Supply Chain (IMSC) sites and supports Malvern Clinical Operations in full compliance with established cGMP and IMSC requirements. Activities include managing in-process testing, raw material testing, environmental monitoring sample testing, utility sample testing, validation sample testing, stability sample testing, method transfer and method validation sample testing, testing of reagents, media, and buffers, and other samples as appropriate.

Other non-testing activities include sample management, equipment lifecycle management of QC Instruments, and management of lab systems including eLIMS and Empower. Responsible for managing QC budget. Develops and implements long-term strategy, and execution of Quality Control programs. Ensures department staff complies with all J&J, IMSC and government-issued environmental, health, safety, quality and regulatory policies and guidelines, including FDA, EMEA and regulatory bodies of any applicable non-EU countries

This role is responsible for carrying out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, training employees, appraising performance, rewarding and disciplining employees, addressing complaints and resolving conflict.

Physical Requirements/ Working Conditions

Ability to lift 10lbs

On site position with opportunity for hybrid work based on management discretion and business needs.

Major Duties & Responsibilities

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…