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Quality Manager

Location: 

Milton, ON, CA

Req ID:  1982
Job Type: 
Edgewell is a global team of over 6,000 visionaries, doers and makers. Our secret is people, and we have an inspiring and collaborative global force of them. Our portfolio of over 25 brands touches lives in more than 50 countries by making useful things joyful. Together, we reimagine good mornings and endless summers, strive for more sustainable ways to beautify and bond, and do it all with not only confidence but determination.

QUALITY MANAGER - MILTON, ONTARIO

Position Summary

 

The primary responsibility of the Quality Manager is to ensure continuing excellence and compliance in the Quality system across all the regulated sites in Canada which includes Milton (Distribution) and Hanover (Packaging)  The incumbent will ensure ongoing compliance with all applicable regulations, ensure all compliance plan deliverables are achieved, maintain all operations in full inspection-ready fashion, foster a mindset of continuous quality improvement, and be a leading voice in sustaining a culture of excellence.  Responsible for managing, coaching, and inspiring a high performing Quality team.

 

Universal Accountabilities

 

  • Ensure compliance with all Health Canada, and GMP requirements for OTC, Cosmetics, and Devices.
  • Ensure that quality systems are implemented and followed in Milton and Hanover (e.g. temperature monitoring, calibration program, document control, product testing, specifications, control procedures, etc.).
  • Release of Finished Goods and/or Raw Materials.
  • Prioritize and direct the work of Quality personnel and communicate timetables and standards of excellence regularly to ensure commitments are met.
  • Lead the quality team by providing coaching, motivation, and direction.  Model the organization’s values and behaviors and engage the team to do the same.
  • Plan and implement Quality strategies, policies, and objectives in accordance with Company strategic plans (SOPs).
  • Provide growth and development for the team and work to have successors in place.
  • Actively participate in Regulatory and Internal Inspections.
  • Escalate to upper management any issue that potentially can impact release of product to market.
  • Collaborate with multidisciplinary teams. 
  • Champion the quality culture and build outstanding partnerships with operations, supply chain, regulatory, commercial, and other functions based on mutual candor and continual bidirectional learning.

 

Specific Accountabilities
 
  • Incumbent is responsible for the release of all imported product.
  • Is the primary contact for interactions with Health Canada.
  • Provides input and manages against a planned budget.
  • Must stay current and be well-versed in all aspects of all applicable regulations.
  • Ensure that personnel are properly trained to successfully accomplish job duties and responsibilities.
  • Responsible to respond to all inspections and ensure all applicable actions are taken to ensure compliance.
  • Frequent travel to Hanover.
     
Required Skills and Experience

 

  • Bachelor of Sciences degree with at least 10 years of experience in leading Quality Systems and Inspections in Canada with direct accountability for product release and HC accountability in Cosmetic/Drug/NHP/Med Devices.
  • Full command of GUI-001.
  • Expert knowledge of ISO 13485:2003 and ISO 22716:2007
  • Knowledge of FDA, ICH guidelines.  
  • Knowledge of safe work practices and Ontario Health and Safety Act.
  • Proficient with various computer software programs and use of audiovisual tools.
     

 

 

Preferred Skills and Experiences

 

  • Working knowledge of Distribution and Packaging of imported products in Canada.
  • Working knowledge of Canadian Medical Device Regulations SOR/98-282.
  • Results oriented analytical thinker with strong problem-solving abilities.
  • Collaborative in approach with the ability to influence the decision-making process.
  • Excellent interpersonal and communication skills at all levels both within and outside the organization.
  • Strong initiative and organizational and project management skills.
  • Ability to successfully work within and promote a team environment.
     
    Working Relationships
     
    •     Internal contacts: Cross-functional team (Purchasing, Operations, Quality, R&D, Engineering, Human Resources, technical support groups) as well as other value streams.
    •     External contacts:  Consultants, contract laboratories, research organizations – technical partnerships such as trade organizations.
     
    Work Environment
     
    •     Be aware of and follow the Environmental Policy and EH&S work instructions/procedures that apply to the job.
    •     Work schedules may vary from typical business hours.
    •     Exposure to health risks or conditions that may require the use of Personal Protective Equipment.
    •     Must be able to travel to off-site locations for meetings; occasional overnight travel required.
    •     Occasional work to match production hours, i.e. potentially 5-10 hours in the evening or on a weekend.
     
    Environmental, Health and Safety Responsibilities
     
    •     Conform to safety regulations and procedures to maintain a safe working environment.
    •     Be aware of and follow the Environmental Policy and EH&S work instructions/procedures that apply to the job.
    •     Perform every job safely, for the benefit of self, co-workers, contractors, and for the protection of facilities.  This includes the use of required personal protective equipment and use of safety equipment/devices, guarding, as well as safe work practices.
    •     Immediately reporting every job-related injury or illness, regardless of severity, to the appropriate party.
    •     Assist in accident investigations.
    •     Take necessary actions to correct or stop unsafe conditions or practices.
    •     Actively participate in safety meeting and training.
    •     Review SDS instructions before working with any chemicals or hazardous materials
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Edgewell endeavors to make its recruitment process accessible to any and all users.  Reasonable accommodations will be provided, upon request, to applicants with disabilities in order to facilitate equal opportunity throughout the recruitment & selection process.