Manager, Inventory Quality

Merz Therapeutics; Burlington; On-site; CAD 80,000 - 100,000; Full time

Job summary

A private family-owned pharmaceutical firm in Canada is seeking a Manager Inventory Quality to oversee batch release operations and coordinate product launches for the Canadian and US markets. This role demands at least 7-10 years of experience in pharmaceutical quality assurance and requires a Bachelor's Degree in a relevant scientific field. The ideal candidate will have a strong understanding of GMP regulations and will manage both local and North American quality operations.

Qualifications

• Bachelor's Degree in a Scientific discipline is required.
• At least 7-10 years of pharmaceutical quality assurance experience.
• Knowledge of GMP regulations essential.

Responsibilities

• Oversee and manage batch release operations for drug products.
• Coordinate new product launches and maintain product master binders.
• Review documentation for incoming product shipments.
• Act as primary contact for recall strategy execution.
• Manage quality issues with Contract Manufacturing Organizations.

Skills

Fluency in English

Strong critical thinking

Computer Literacy

Warehouse Management Systems

Inventory Control

Education

Bachelor's Degree in a Scientific discipline

Tools

SAP

Microsoft Dynamics Navision

Job description

Step into the future with us at Merz Therapeutics where our family roots meet a bold new. Together we're embarking on a transformative journey blending time‑honored traditions with exciting new products.

As a private family‑owned company, we have the liberty and support to make decisions for ourselves, our customers and the patients we serve. We pride ourselves on building an inclusive culture where there is room to celebrate individual growth with the ability to contribute to a common good as a collaborative team. Our mission is grounded in a long‑term view of making a difference for the common good while growing together as a family.

If you're looking to immerse yourself in a passionate team rooted in community connection and camaraderie then we're looking for YOU! #IAmMerz

Are you ready to galvanize a team around a culture of care putting patients first to spark change?

The Manager Inventory Quality will be responsible overseeing and managing batch release operations for drug products, components, medical devices and marketing materials for Canadian and US markets. This role will oversee all things inventory including coordinating new product launches, maintenance of product master binders, finished goods release to market, leading recalls and relationship management with 3PL. This role is based in Canada but helps serve a Quality Assurance team responsible for North America (operations for Canada and USA). Primary responsibilities for this role will be for Canadian QA operations with expansion to support North American operations once the Canadian activities are launched and functioning at a maintenance level.

Responsibilities

• Product Release Management
  

  New product set‑up and coordinating launch readiness activities.

• Raising change controls for product updates / launches
• Maintaining product master binders
• Maintaining Drug Establishment License activities with Regulatory Affairs team
• Reviewing all documentation for incoming product shipments (batch records, product specifications, certificates, etc.) and providing authorized QA disposition.
• Recall Management
  

  Primary contact for recall strategy execution reporting, performing annual mock recalls, authoring recall / mock recall reports.

• Product Quality Oversight of Inventory
  

  Working through large inventory discrepancies requiring investigation, dispositioning product returns, maintenance of retains, reconciliation of stock for destruction, revision of Annual Product Quality Reviews (APQR).

• Working with Contract Manufacturing Organizations (CMOs)
  

  Facilitating and resolving quality issues with CMOs and internal stakeholders, ensuring products meet all required quality standards and specifications.

• Relationship management with 3PL
  

  Monthly team meetings, troubleshooting, raising issues to Supplier Management and Supply Chain teams.

• Helping to review quality agreement / Client Manual updates with 3PL.
• Quality Assurance Diligence
  

  Adhering to QA key performance indicators (staying on top of deviation investigations and closure CAPA actions and closure change control actions and closure, etc.).

• Staying informed about regulatory changes affecting products / processes, authoring / reviewing SOPs.
• Contributing to Quality Management Reviews and quality team meetings.
• Collaborating with local and global quality safety regulatory and supply chain teams.
• Participating in cross‑functional projects maintaining compliance with Global Therapeutics Quality Management System.
• Additional responsibilities as assigned
  

  Supporting local leadership in any quality objectives as applicable.

• Staying up to date on SOP reading / training requirements.
• Notifying manager of regulatory compliance questions and issues, backing up to team members as needed, etc.

Education & Certifications

• Bachelor's Degree in a Scientific discipline (Health Science, Science, Biology, Chemistry, Pharmacy or related field) is required.
• A degree from a Canadian institution or an internationally recognized equivalent credential is a requirement for this role.
• Certification from an accredited Quality Assurance body considered an asset.

Professional Experience

• At least 7‑10 years of drug pharmaceutical quality assurance experience in a role directly involved with manufacturing batch record review and/or drug product release.
• Biologic and medical device release experience considered an asset. Familiarity with oral solid dose, oral solution, lyophilized and sterile product presentations is desirable.
• Responsibility for release of several drug presentations to the Canadian market and ability to explain the process in detail as a subject matter expert.
• Well versed in drug product manufacturing processes and GMP regulations for both Health Canada and FDA.
• Knowledge and experience launching a new product at a company is required along with handling change controls and mapping out required steps for launches.
• Experience / familiarity with product acquisitions and product technical transfer process is also desirable.
• Experience handling or participating in at least one drug or medical device product recall or mock is required.
• Has investigated and processed complex deviations, managed CAPAs to closure, managed change controls to closure and authored / reviewed / owned SOPs throughout their career.
• Prior experience with Time out of Temperature, Time out of Refrigeration, Mean Kinetic Temperature and Temperature Excursion assessments for imported product shipments is required.
• Understanding of the Health Canada regulatory landscape, maintaining Drug Establishment Licenses and foreign building tables is considered an asset.
• Participation in a Health Canada inspection as a host or subject matter expert considered an asset.
• Experience in a 3PL environment performing quality assurance drug product release is considered relevant experience.
• Prior experience utilizing SAP or another ERP system for batch release and product transfers / holds.
• Prior knowledge or experience with product labelling requirements for the Canadian market for domestic and imported products is considered an asset.
• This role is hiring for a manager of a process; no prior people‑managerial experience is required.
• Knowledge of GMP regulations for the EU and USA considered an asset.

Knowledge, Skills and Abilities

• Well versed in drug GMP regulations.
• Knowledge and experience launching a new product in Canada.
• Understanding of the Health Canada regulatory landscape, maintaining Drug Establishment Licenses and foreign building tables; asset.
• Knowledge of GMP regulations for the EU and USA; asset.
• Fluency in English is required with exceptional writing skills and ability to articulate quality concepts.
• Fluency in French is considered an asset.
• Ability to juggle multiple items at once and prioritize activities.
• Strong self‑motivation, can‑do attitude, and solutions‑oriented mindset.
• Strong critical thinking and decision‑making skills.
• Team player who actively collaborates with team members and colleagues from other sites.
• Experience working with diverse people, organizational cultures, and supporting individuals with varied backgrounds and attitudes.

Travel Requirements

There may be an occasional to the US headquarters a few times per year (up to once per quarter). There may be a trip to the German headquarters once every other year. The candidate may visit the 3PL facility on an as‑needed basis.

Equal Opportunity Employer

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities.

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information please review the Know Your Rights notice from the Department of Labor.

Key Skills

• Kanban
• Forecasting
• Inventory Control
• Math
• Warehouse Experience
• Microsoft Dynamics Navision
• Warehouse Distribution Experience
• Computer Literacy
• Warehouse Management System
• ERP Systems
• Supervising Experience
• MRP