Apply on Employer Site

Johnson & Johnson Innovative Medicine · 1 day ago

Director Quality Control

Raritan, NJ

Full-time

Onsite

Director/Executive

$150K/yr - $259K/yr

10+ years exp

Johnson & Johnson is a leader in healthcare innovation, dedicated to improving health outcomes through their Innovative Medicine division. They are seeking a Director of Quality Control for their CAR-T Manufacturing facility, responsible for leading the Quality Control team and ensuring compliance with cGMP standards while driving organizational excellence.

Pharmaceuticals

Responsibilities

Develops and implements strategy for cGMP’s compliance for the site

Provides leadership and direction to Quality Control Team to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behavior model

Develops and champions an organizational culture that promotes behaviors that lead to outstanding business performance and organizational excellence

Responsible for appropriately staffing and developing the QC organization to meet business needs and succession plans

Leads launches of new products and technology transfer across the platform

Anticipates and plans for future requirements and agility in the Labs, including such aspects as procedural requirements, capital planning, personnel recruitment planning, compliance requirements, efficiency and optimization objectives and anticipated changes needed to reflect future demand

Establishes effective partnerships with other individuals, departments, and cross- functional teams so that analytical services are well understood and coordinated

Establish proper communication channels to lead and mentor employees to higher levels of management capability and provide strategic leadership to further strengthen the QC operations

Develops and controls budget, organizational structure, and business requirements to accommodate budget and assure metrics are met

Ensure all activities are performed in accordance with GMP in the laboratories, and monitor QC compliance through robust internal audit and leadership oversight programs (e.g. GEMBA)

Qualification

Quality ControlBiologicsCell TherapyAnalytical TestingMicrobiological TestingTrackwiseELIMSInfluencing SkillsCommunication SkillsInterpersonal SkillsCollaboration Skills

Required

A minimum of a bachelor's degree in Science is required, preferably in Biology, Microbiology, Chemistry, Pharmacy, Biochemistry, or related Science or Engineering

10 years of proven track record in biologics and/or cell therapy Quality Control laboratory operations, with 5 of those years managing at the senior level

Demonstrated success in leading a large scale QC lab

Experience in hosting global regulatory agency inspections and successfully communicating quality control programs to regulatory reviewers

Experience with Trackwise and eLIMS

Excellent communication, interpersonal relation, collaboration, and influencing skills

Preferred

Quality Control (QC)

Benefits

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 period

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year