Mgr Quality Control

Johnson & Johnson Innovative Medicine•Malvern, PA

22h•Hybrid

About The Position

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.

Requirements

Benchmarking
Compliance Management
Developing Others
Human-Computer Relationships
Inclusive Leadership
Leadership
Operational Excellence
Performance Measurement
Product Testing
Quality Control (QC)
Quality Management Systems (QMS)
Quality Standards
Quality Validation
Standard Operating Procedure (SOP)
Tactical Planning
Team Management

Responsibilities

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.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits