Commercial Quality Manager

Johnson & Johnson MedTech is currently seeking a Manager, Commercial Quality to be located at MedTech site in Canada (JJMT).

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential. At Johnson & Johnson, we all belong.

Our Commercial Quality Manager is responsible for providing high performance quality systems leadership, guidance, and support for shaping, monitoring, assessment, and implementation of key Quality Systems processes to maintain continuous compliance with standards and Health Canada regulations, while balancing and continuously improving the customer experience.

KEY RESPONSIBILITIES
- Provides strategy, expertise and process ownership of core JJMT procedures
- Connects with many leaders across the organization, synthesizes all feedback and ideas into a cohesive quality system strategy for JJMT.
- Shape, implement, maintain and continuously improve JJMT Quality System to support the business and comply with Government and J&J requirements
- Drive key decisions across JJMT Commercial, ensuring alignment, to deliver a fit for purpose quality management system processes and procedures.
- Lead collaboration efforts with global counterparts to support Quality Systems Digitization, Simplification and Harmonization efforts
- Build and maintain strong relationships with internal/external stakeholders including regulatory agencies, MedTech business units, global counterparts, and JJMT Canada Commercial
- Lead and foster talent development, and empower direct reports to execute with speed, transparency and accountability to ensure appropriate Quality KPI/Metrics are met, Goals & Objectives are achieved and continuously improve customer experience
- Reviews metric monthly dashboards and partners across JJMT establishing improvement plans to address below target metrics and negative trends
- Oversee Purchasing Control requirements for suppliers, distributors and facilitate supplier selection, audits, on-going performance monitoring process
- Oversee Quality Issue-related Programs (Escalation, CAPA, NCs, Risk/Impact Assessments) and monitor compliance
- Oversee Document Control, Training, Change Control programs and monitor compliance
- Oversee Field Actions impacting JJMT product to ensure timely actions are taken to rectify the situation
- Host Internal and External Audits locally, and assist during Business Unit Health Authority/Notifying Body Inspections
- Implement and maintain Quality Agreements with Partner Companies, Suppliers and Distributors
- Provides quality systems and compliance expertise to support new product launches, Go-to-Market models, Service and Repair and Repack-Relabel initiatives
- Support Drug Compliance and adherence to Good Manufacturing Practices for drug/biologic products
- Oversee JJMT’s Internal Audit program
- Maintain awareness of industry issues, trends and changes in regulation and policy: Provides industry feedback to MedTech Industry Association & Health Canada; interprets and assesses the business impact; and develops implementation strategy
- Prepare and present quality compliance information at Management Reviews
- Provides quality system & compliance support to Distribution Centre activities.
- Provide people & organizational leadership, ensuring compliance with J&J policies and processes.

**Qualifications**:
EDUCATION:

- University/Bachelor’s or equivalent degree in a Life Science, Engineering, or Physical Science is required. Completion of post-graduate program in Quality/Regulatory Affairs is an asset.

EXPERIENCE

REQUIRED:

- A minimum of Six (6) years of experience in the Pharmaceutical, Medical Device or Biologics industry.
- Proven experience in successfully collaborating across functions and delivering business results
- Strong documentation skills and technical writing capability.
- Experience in managing health authority and or Notified Body inspections.
- Skills in managing change and implementation of new processes
- Excellent verbal and written communication skills

PREFERRED:

- Experience in Quality system experience and strategic thinking in emerging and changing requirements
- Experience in implementing and maintaining Digital Quality Systems.
- Experience in ISO 13485, ISO 9000 series, Lean, Six Sigma or other Quality Systems Experience an asset

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