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Sr Manager Quality and Compliance- External Manufacturing, Johnson and Johnson, Markham, ON, Canada

Sr Manager Quality and Compliance- External Manufacturing, Johnson and Johnson, Markham, ON, Canada
Posted on: Nov.17.2022

Sr Manager Quality and Compliance- External Manufacturing, Johnson & Johnson, Markham, ON, Canada

JOB TITLE: Sr Manager Quality and Compliance- External Manufacturing
FUNCTION: Quality
SUB FUNCTION: Quality (Generalist)
LOCATION: Markham, Ontario, Canada; Guelph, Ontario, Canada
REQUISITION NUMBER: 2206092276W

DESCRIPTION

Johnson & Johnson Inc. Canada is recruiting for a Sr Manager Quality and Compliance- External Manufacturing , located in Markham or Guelph, Ontario.
Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, Dietary supplements and OTC products.

Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with works councils and other employee representative bodies, as required, and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of a new entity within New Consumer Health and your employment would be governed by New Consumer Health’s employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by New Consumer Health at an appropriate time and subject to any necessary consultation processes.

The Senior QA Manager– External Manufacturing will provide leadership in achieving and maintaining compliance with regulatory, corporate, and sector quality requirements. The position will directly manage Quality Manager(s), EMQ Lead(s) and QA Specialists(s) supporting the oversight of External Manufacturers of Company products with a primary focus on Zarbee’s Brand and Canadian EMs. As an extended leader in the Source Quality organization, this position participates in the development and deployment of strategies, goals, and objectives and directing programs, processes and activities that align to them. This position ensures cross-functional partners are accountable and understand our quality system requirements and how they impact product quality and regulatory compliance.

This position provides guidance to project teams to ensure compliance and quality requirements are met in support of commercial production and/or change control activities related to re-qualification or relocation of existing commercial products. Provides risk-based QA Leadership support and independent decision making for a wide range of technical, compliance, and business issues. This position must actively educate and grow the skills and professional experiences of NA Source Quality personnel to elevate competencies and to develop future Company leaders.

Key Responsibilities:

NA Quality extended leadership team member
Assist in the development, implementation and administration of vision, strategies, plans, goals and objectives designed to assure high quality products, compliance to regulatory authority and Company standards, and efficient/effective processes.
Identify and assess risk associated with externally-manufactured products and processes.
Collaborate with internal and external partners to enhance relationships and interactions.
Provide leadership in the support of critical quality system requirements including CAPA, investigations, Change Control and Approved for Product Release (APR) reviews.
Provide leadership in day-to-day production to meet applicable quality and compliance requirements.
Lead critical roles during internal and external audits/inspections.
Implement process excellence and continuous improvement using techniques aligning with Quality/Manufacturing Excellence programs:
Global Laboratory Initiatives
Support and drive E2E Value Chain Management built capabilities and process simplification
Provide leadership to mentor and develop the EM Q&C team via initiatives related to Company Process Excellence Initiatives
Support the identification of product CTQs and process capability during product/process development and site transfers or new product introductions (NPI). Provide Quality oversight support and necessary response to questions on quality in the new product process, during internal and regulatory inspections.
Develop a fully effective, motivated, engaged, and compliant team of direct and/or indirect leaders and employees.  Develop and implement experience and skill development strategies that best position the team to meet current and future business needs, to include E2E Value Chain Management.

Education:

A minimum of a Bachelor's degree or equivalent is required.
A focused degree in a Science related discipline is preferred. An advanced degree (Master’s/MBA) is preferred.

Experience:

A minimum of 8 years of experience working in a regulated industry is required. Experience in either Dietary & Nutritional, OTC Drug and/or Cosmetic, Pharmaceutical, and/or Medical Device Manufacturing production is preferred
Experience with QA or QC directly or indirectly is required.
Working knowledge of cGMP requirements, current FDA enforcement issues and current regulatory authority enforcement practices is required.
Working knowledge of NPI, process validation and qualification, cleaning validation and qualification, manufacturing and packaging equipment train designs, microbiological controls, and assessing compliance to regulations is required.
Experience in managing quality activities for large volume external and/or internal manufacturing and supplier sites ensuring compliance with applicable regulations.
Demonstrated ability to collaborate with internal and external partners to enhance relationships and interactions.
Experience in the facilitation of internal and external audits and regulatory inspections is required.
Experience in data analysis to drive improvements in processes to drive success
Professional Certification with Six Sigma Black or Green Belt is preferred.

Other:  

This role is based in Markham or Guelph, ON Canada but may require up to 25% domestic and US travel based on business needs

Knowledge, Skills and Abilities:

Demonstrated ability to build respectful and productive relationships with subordinates, peers and leadership partners across multiple responsibility levels and within a high matrix structure
Demonstrated skills navigating within a matrix environment, managing complexity, collaborating across boundaries and influencing with and without direct line authority
Strong communication (verbal, written, and presentation) and interpersonal skills, self-awareness and adaptability required
Demonstrated ability to lead as a key team member, developing strategy/plans and implementing successful outcomes
Demonstrated working knowledge of KPIs and driving success through Quality Excellence
Results-oriented with strong track record of success in delivering on objectives
Ability to work in a fast-paced environment with multiple, concurrent priorities many needing immediate resolution

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of full COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit http://www.careers.jnj.com/.
Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies.  Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success.  We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.

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