Mgr Quality Control

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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 organizations 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 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.
• Provides input to product quality complaint investigations.
• Prepares for and provides QC expertise during Health Authority inspections as required.
• Influences senior leaders and external colleagues/partners across disciplines as well as globally in driving and aligning strategic and operational activities between business units/functions.
• Monitors departmental metrics and delivers reports to senior management as necessary.
• Manages strategic capital projects.
• Supports and leads global initiatives and implementation at the local level.
• Allocating resources and confirming alignment of changes with site strategies in the change management processes within functional areas.
• Proactively evaluates and facilitates remediation of compliance risks.
• Serves as a lead and/or SME during quality audits and inspection activities.
• Coordinates and is accountable for inspection responses as required.
• Support daily activities for scope of functions as needed.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

Additional Description for Pay Transparency:

Manager