Manager, Inventory Quality

Step into the future with us at Merz Therapeutics, where our family roots meet a bold new vision. 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.

Essential Duties and 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, backup 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 international degree formally recognized as an 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 Temp, 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 previous people managerial experience is required.
• Knowledge of GMP regulations for the EU and USA considered an asset.

Knowledge, Skills, and Abilities

• It is required that the candidate is well versed in drug GMP regulations.
• Knowledge and experience launching a new product in Canada is required.
• Understanding of the Health Canada regulatory landscape, maintaining Drug Establishment Licenses and foreign building tables is considered an asset.
• Knowledge of GMP regulations for the EU and USA also considered an asset.
• Fluency in English is required, with exceptional writing skills and ability to articulate quality concepts.
  • Fluency in French is considered an asset.
• The candidate is able to juggle multiple items at once and is good at prioritizing acitivites.
• The candidate strives to deliver things on time and pushes to meet KPIs.  The candidate is strongly self-motivated, has a "can-do" attitude and dives in with a positive outlook and solutions-oriented mindset.
• Strong critical thinking and decision-making skills are an asset.
• The successful candidate is a team player and actively collaborates with team members and colleagues from other sites.
• Working with different people and organizational cultures, supporting people with diverse backgrounds, attitudes and cultural differences is required.

 Travel Requirements

• This role does not require routine travel.  There may be an occasional trip 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 once in a while but this is not customary.

Don't meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Merz Therapeutics we are dedicated to building a diverse, inclusive, and authentic workplace, so if you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles.

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