Quality & Regulatory Manager - Cpg/personal Care

1 week ago

Barrie, Ontario, Canada HK Kolmar Canada Full time

Must have at least 5 years leadership experience on CPG/Cosmetics/Personal Care Manufacturing


Kolmar Canada is a Barrie, ON based manufacturer of personal care and cosmetics products in business for over 65 years.

We have an exciting opportunity for an experienced, driven Quality & Compliance Manager with experience in the Skincare & Cosmetics industry If you are interested in joining a fantastic team on the cutting edge of the industry, we encourage you to apply

General Description:


The Quality Assurance (QA) & Regulatory Affairs (RA) Manager will be responsible for all QA & RA functions as it relates to Cosmetic and Personal Care products that are manufactured and/or distributed by the Company in alignment with regulatory agencies.

Leading their team and supporting all operations, they will promote quality, efficiency, and Good Manufacturing practices to achieve company objective.

The Quality Assurance & Regulatory Affairs Manager will support the safety and effectiveness of product and meet business objectives in a compliant and efficient manner.


Duties & Responsibilities:

Provides leadership and direction the Quality and Regulatory team ensuring the necessary resources, tools and supports are available.

  • Provides leadership and direction the Quality and Regulatory team ensuring the necessary resources and supports are available.
  • Oversee training and performance management to Quality and Regualtory team.
  • Reports to leadership team on all regulatory and quality issues.
  • Organize, prep and lead all Regulatory and Customer audits (Health Canada, FDA)
  • Liaises with government and regulatory organizations to ensure compliance with current regulatory and licensing requirements.
  • Monitors Good Manufacturing Practices (GMP) and applicable documentation.
  • Oversee the development and maintenance of Standard Operating Procedures to ensure efficiency and compliance.
  • Remains current on all Health Canada & FDA regulations and policies; recommends and implements appropriate compliance strategies where required.
  • Oversees and provides direction on regulatory documentation and submissions including, but not limited to Site Licenses/regulations.
  • Maintain adequate resources for all relevant facilities for company quality program.
  • Provide input on company policies and direction to leadership team.
  • Develop quality programs through SOP's and implement process review to maintain compliance with all regulations.
  • Assure adherence to budgets, schedules, work plans, and performance requirements.
  • Prepares Deviation/Incident Reports.
  • Review and approve CAPA for deviation.
  • Manages the storage of retained samples.
  • Revise GMP documentation via the change control system
  • Assess procedures currently in place for compliance. Identify gaps and make recommendations on improving compliance.
  • Ensures that all the work is performed in accordance with SOPs and procedures, and global regulatory requirements (ICH, FDA, HC, GMP).
  • Ensures GMP training is completed and documented within the required timelines

Qualifications

Education:

Bachelor of Science/Chemistry and relevant post-secondary education in quality and/or regulatory

Experience:

  • 10+ years of experience in compliance, quality assurance, regulatory affairs and document management in Cosmetics/Personal Care manufacturing industry
  • 5+ years' experience managing the audit process and working with regulatory agencies including Health Canada/FDA compliance.
  • 5+ years leadership experience managing 10+ direct reports.
  • Strong background in analyzing technical documents, interpreting processes and procedures, regulations, and industry standards.
  • Excellence in document management and control
  • Experience in preparing regulatory submissions.
  • Strong communication skills and demonstrated team management.

Knowledge/Skills:

  • Ability to build and maintain positive and effective relationships with all stakeholders.
  • Thrive in an intense, fastpaced, changing environment.
  • Analytical and diligent with exceptional time management skills
  • Highly effective oral and written communication skills
  • Strong leadership skills with collaborative approach

Salary:
From $85,000.00 per year

Benefits:

  • Casual dress
  • Company events
  • Company pension
  • Dental care
  • Disability insurance
  • Employee assistance program
  • Extended health care
  • Life insurance
  • Paid time off
  • Vision care

Flexible Language Requirement:

  • French not required

Schedule:

  • Day shift
  • Monday to Friday

Supplemental pay types:

  • Bonus pay

Ability to commute/relocate:

  • Barrie, ON: reliably commute or plan to relocate before starting work (required)

Education:

  • Bachelor's Degree (required)

Experience:

  • CPG/
Personal Care Manufacturing: 5 years (required)

  • Leadership: 5 years (required)
- regulatory/customer auditing: 5 years (required)

Work Location:
In person

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