Senior Manager, ATSC External Quality

Johnson & Johnson•Gaithersburg, MD

12d

About The Position

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 & Compliance Audit Job Category: Professional All Job Posting Locations: Gaithersburg, Maryland, United States Job Description: Johnson and Johnson is recruiting a Senior Manager, ATSC External Quality located in Gaitherburg, Maryland.

Requirements

A minimum of 8 years working in an FDA/EMA regulated environment
Extensive knowledge of Quality Assurance, Quality Control and Compliance.
Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production
Experience managing quality oversight for commercial manufacturing operations
Experience working with external partners
Experience in aseptic pharmaceutical manufacturing
Experience in CART manufacturing, testing and release
Strong interpersonal and written/oral communication skills
Ability to take ownership for and own the resolution of complex Quality and Compliance issues with respect to External Manufacturing.

Nice To Haves

Experience in building a new supply chain
Experience in CART or Biologics products
People management experience

Responsibilities

Provide quality leadership and technical support to ensure effective and compliant execution of quality systems at external manufacturing sites working in the CART space
Manage quality oversight in the selection, qualification, and ongoing monitoring of external partners
Provide oversight for tech transfer and new product introduction activities in the CART space; lead PAI readiness activities, and support associated health authority filings and approvals
Daily management and coordination of the EQ work team supporting the EM as needed
Lead the identification and resolution of quality issues and complaints, including facilitation of investigation process and development of robust CAPA plans.
Review and approve quality systems documentation, including product disposition, manufacturing instructions, change controls, specifications, validation documentation, and technical studies
Supervise quality performance through the development of key performance indicators; Analyze data to identify risks and drive implementation of mitigation plans
Build relationships with internal and external partners; Influence external manufacturers to continuously improve processes and procedures passionate about reliability, execution, and quality culture
Collaborate with External Manufacturers to support health authority inspections; supervise and follow-up on associated response and commitments
Partner with External Manufacturing sites to define the quality strategy through benchmarking and knowledge sharing.
Lead risk management initiatives vital to improve performance
Partner with key internal stakeholders in support of tech transfer and supply chain processes to meet patient supply requirements
Assess current quality systems and recommend improvements to improve compliance and optimize processes

Benefits

medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
consolidated retirement plan (pension)
savings plan (401(k))
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 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
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours