Upsher-Smith

Manager, QA Operational Quality

Upsher-Smith$91K — $114K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 5-10 years of experience in the pharmaceutical industry preferred.
  • Bachelor's degree in Science or related field or equivalent experience required.
  • Previous role in operational quality assurance or similar responsibilities.
  • Strong knowledge of regulatory frameworks and good manufacturing practices (GMPs).
  • Ability to lead projects and influence team members effectively.
  • Proficient in external communications with customers and stakeholders.
  • Strong interpersonal and communication skills.

Responsibilities

  • Ensure quality of ointments, creams, and liquids (OCL) as well as solid dose products.
  • Oversee the release of manufactured and packaged products.
  • Investigate deviations in manufacturing and testing, determining root causes and corrective actions.
  • Supervise quality activities across all shifts at the facility.
  • Approve product complaint investigations and periodic product reviews.
  • Manage the site’s validation program and evaluate planned changes in materials and processes.
  • Conduct pre-approval inspections and respond to inquiries from regulatory and internal auditors.
  • Oversee customer recalls and act as quality liaison for customer relations.
  • Lead and mentor the quality team to enhance operational effectiveness.

Benefits

  • Comprehensive health coverage including medical, dental, and vision insurance.
  • Retirement savings plans with employer contributions.
  • Paid time off and flexible work arrangements.
  • Professional development opportunities.
  • Employee wellness programs and resources.
  • Employee Assistance Program and Mental Health Resources.
Full Job Description
Position Status

This is a fulltime permanent and a backfill position. The role is an active, approved vacancy within the organization and is intended to support current staffing needs.

General Description

Quality Manager is responsible for management of the operational quality activities to ensure product quality and compliance is maintained and to manage staff accountable for operational quality deliverables.

Responsibilities
  • Ensure the quality of ointment, creams and liquid (OCL) products and/or Solid Dose products manufactured and packaged at Bora Mississauga.
  • Oversee release of OCL and Solid Dose products .
  • Responsible for investigation of deviations pertaining to manufacturing, packaging and testing of OCL and Solid Dose products, identifying true root cause of incidents and assigning corrective and preventative actions. Also identifies and investigates trends.
  • Oversees shift oversight activities for all shifts on site.
  • Approves complaint investigations for OCL and Solid Dose products identifying true root cause of incidents and assigning corrective and preventative actions.
  • Approves periodic product reviews for OCL and Solid Dose products.
  • Overseas validation program for the site • Evaluates and approves planned changes pertaining to OCL and Solid Dose raw materials products processes and equipment.
  • Hosts pre-approval inspections for OCL and Solid Dose products and may co-host other inspections and audits. Responds to queries from regulatory authorities, third party auditors and internal auditors.
  • Responsible for providing Bora quality oversight for customer recalls of products manufactured packaged by Bora Mississauga.
  • Act as a Quality point of contact with Customer.
  • Leads, coaches and mentors team.
  • Leads staff to optimize operational effectiveness.
  • Manages performance process and career development of staff.


Experience & Skills
  • Experience in operational quality assurance or related role with similar responsibilities.
  • Demonstrated effective management of issues.
  • Experience with external communications with customers.
  • Sound knowledge of regulatory framework and ability to make informed decisions and release product to market as per GMPs.
  • Demonstrated ability to lead projects or change initiatives.
  • Demonstrated ability to influence and lead others as well as the ability to make sound quality decisions.
  • Strong interpersonal and communication skills.


Education
  • Required: Bachelors degree in Science or related field or equivalent on the job experience through years of service.
  • Preferred: 5-10 years in the pharma industry.


Working Condition
  • Flexibility with Onsite Work Schedule and Occasional Extended Hours.


Additional Information

In accordance with Ontario's pay transparency requirements, candidates will be notified when they are no longer under consideration or once the vacancy is closed. Updates regarding application status may be communicated via email or through the online applicant profile, where applicable.

As part of our recruitment process, we may use technology-assisted tools, including automated systems, to support the review and assessment of applications. These tools do not make final hiring decisions. All decisions related to screening, interviewing, and selection are made by our Talent Acquisition and hiring teams.

Compensation Range

$91,410 - 114,260

Benefits Include:

We offer a comprehensive benefits package designed to support our employees' wellbeing, including:

-Competitive salary and performance-based incentives

-Comprehensive health coverage including medical, dental, and vision insurance

-Retirement savings plans with employer contributions

-Paid time off and flexible work arrangements

-Professional development opportunities

-Employee wellness programs and resources

-Employee Assistance Program and Mental Health Resources

About Upsher-Smith

Upsher-Smith Laboratories, LLC is a pharmaceutical company headquartered in Maple Grove, Minnesota. The company was founded in 1919 and is now a subsidiary of Sawai Pharmaceutical Co., Ltd. Upsher-Smith develops, manufactures, and markets prescription and over-the-counter products in the areas of women's health, dermatology, cardiology, and neurology. The company has a strong commitment to quality and innovation, and is dedicated to improving the health and well-being of patients.
Learn more about Upsher-Smith
Size
1,000 employees
Industry

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