J&J Family of Companies Quality Systems Analyst III in 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, and OTC products.

This position’s primary responsibility is to develop and implement quality systems based on business, regulatory and customer requirements. Also provides training and consultation to various parts of the business and resolves procedural breakdowns. This role has responsibility for Change Management, SAP Master Data, Specifications Management and Systems Support. These Quality Systems activities support both product launch and product release processes. Issue resolution and root cause determination are key assets of the role ensuring customer engagement and adherence to procedural requirements. The role interacts regionally to influence effective solutions to individual market requirements and document management processes for North America Business Quality. This role ensures that J&J Inc. Canada operates in compliance with internal procedures, Canadian regulatory requirements and Johnson & Johnson Quality Standards.

MAJOR RESPONSIBILITIES:

• Manages change management processes including;

‐ Process Owner of Change Management Standard Operating Procedures and assessments to Worldwide SOPs and Quality Standards

‐ Local Change Control Process Owner, facilitating weekly change control meetings

‐ External Change Control review (external manufacturers and affiliates) for impact on Canadian products

‐ ETQ admin – Facilitating system access and communication and support of system maintenance

‐ Ensure Change Management Process (local Change Control, Global, External Manufacturing) meets regulatory and corporate requirements

‐ Provide consultation and support to business partners and customers with regards to projects, issues management, planning and resolution

‐ Participant on the Global Change Control Forum and Change Control Review Boards

‐ Track, report and improve monthly Change Control metrics, to drive on-time completion

• SAP Power User and go-to person for related issue resolution, collaborating with the Regional Master Data team and GMP approver for Quality Data requirements

• Creates, revises and approves specifications for J&J Canada products to meet corporate, regulatory guidelines requirements

• Responsible for the management of the Co-op student resource

‐ Recruiting and hiring of co-op student personnel

‐ Management of training and development, task prioritization and resource management across teams

• Seeks out and leads continuous improvement opportunities in daily work operations through customer interaction. Works with customers to develop business case for project activity and prioritizes projects by value

• Promotes and expands Compliance Culture through training, mentoring and maintaining open communication with all business partners

• Leads or represents team on Quality & Compliance Task Forces/Committees as required

• Living our Credo as an engaged team member, creating a trusting and collaborative environment

• Active participation in Credo team initiatives locally and regionally

• Manages/completes activities as outlined in the Goals & Objectives

• Acts as a delegate for Manager, Quality Systems Canada

Qualifications

EDUCATION AND EXPERIENCE:

• A minimum of a Bachelor’s Degree in Chemistry, Engineering, Life Sciences, Pharmacy or similar disciplines required

• A minimum of 5 – 8 years of experience working in a regulated industry is required, with strong understanding of GMP standards related to pharmaceutical products.

• Knowledge of GMP/GLP regulations and guidelines is a requirement

• Knowledge of and competence in the application of Health Canada GMPs, ICH Guidelines

• Knowledge of Process Excellence tools, thinks analytically and acts decisively

• Strong interpersonal skills and effective performance management skills

• Ability to work on multiple projects simultaneously

• Strong problem solving, partnering, and communication skills

TECHNICAL COMPETENCIES:

• Working knowledge of SAP master data and user profiles

• Working knowledge of ETQ Symphony – Change Control and CAPA modules beneficial

BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

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.

Primary Location

Canada-Ontario-Guelph

Organization

Johnson & Johnson Inc. (7695)

Job Function

Quality (Generalist)