Commercial Quality Site Lead

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Bridgewater, Massachusetts, United States of America

Job Description:

Overall purpose of job:

The Commercial Quality Site Lead is responsible for the oversight and execution of Quality and Compliance (Q&C) programs at the Value Added Service Center (VASC) located in Bridgewater, MA.

This position serves as a liaison with Quality and Supply Chain partners, and the MedTech DELIVER team on field returns quality related matters and collaborates with the DePuy Synthes and MedTech DELIVER NA organizations to drive timely resolution of quality related issues. This position identifies and supports implementation of improvement opportunities consistent with DELIVER NA business objectives and the Enterprise Quality Standards.

This position is accountable for development, execution and oversight of quality and compliance programs designed to meet customer and business needs in compliance with regulatory requirements and the Quality Management System.

Key responsibilities:

• Responsible for quality & compliance oversight of the Value Added Services operations at the site including Returns, Set Assembly, Torque Testing, Donations, etc.

• Responsible for the management of all internal (ERC) and external Health Authority inspections (e.g. FDA, TUV/BSI) conducted at the site, including reviewing the preparation plan with on-site management.

• Ensure returned product is dispositioned according to predefined agreements with Operating Company, Franchise, or Marketing Company.

• Define and implement quality requirements and systems in alignment with department strategy.

• Support execution of the Quality System for the site.

• Ensure the Quality program maintains regulatory compliance.

• Support cross-functional teams to identify, investigate, document and correct quality issues related to the field returns process.

• Provide quality support for technology transfer and improvement of existing distribution processes including ensuring change control requirements are met.

• Support development of and review and approve standard operating procedures.

• Support registration maintenance for the site, as the need arises.

• Facilitate, coordinate and assist in Supplier Audits, when applicable.

• Make proposals and assist in the development of corrective action plans and monitor implementation including follow-up on closure and metric reporting of CAPA, NC, and audit observations, as applicable.

• Establish and maintain relationships with NA DELIVER & Franchise customers in order to solve problems and meet changing competitive and regulatory environments.

• Coach and mentor Deliver business partners in the areas of root cause analysis, ISO and cGMP requirements as needed.

• Performs other related duties as required.

Required Qualification and Core Competencies for the role:

EDUCATION:

A Bachelor's or equivalent University degree is required, with a focus in science, engineering, technology or math preferred.

EXPERIENCE AND SKILLS:

REQUIRED:

• 5-7 years of relevant experience in regulated healthcare industry.

• Knowledge of FDA 21 CFR Part 820 and/or ISO 9001 and/or ISO 13485

• Business experience in regulated industry in a fast paced, dynamic, global operation.

• Ability to develop and administer a strategic audit plan that optimizes compliance and minimizes customer risk.

• Strong communication and collaboration/influencing skills to partner effectively across functions and operating units.

• Self-directed and motivated with flexibility to work independently and on teams.

• Demonstrated time and project management skills to handle multiple projects and deadlines.

• Strong problem solving and analytical experience.

• Innovative, quality, and global mindset.

PREFERRED:

• Experience within a diverse organization.

• Experience in health care industry

• Process Excellence Belt.

• Knowledge of ERP systems

Job locations:

Bridgewater, MA

May require up to 20% travel

Required Skills:

Preferred Skills:

Audit Management, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)

The anticipated base pay range for this position is :

$94,000.00 - $151,800.00

Additional Description for Pay Transparency:

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.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

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