Based in the Raleigh, NC Corporate office - Hybrid

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, Audits and Supplier Management will be responsible for further development and oversight of the Supplier Management Program and Internal Auditing Program. The role will be the Liaison to global Quality functions and will focus on compliance of operations with quality related requirements set by authorities and Merz-internal. This role is based in Raleigh but helps serve a Quality Assurance team responsible for North America (operations for Canada and USA).

Essential Duties and Responsibilities

• Supplier Management
  • Overseeing and contributing to the Supplier Management program through supplier qualification activities, supplier audits, maintaining contracts, monitoring supplier performance, monitoring, tracking and investigating supplier deviations and issuing SCARs where required
  • Maintaining the audit schedule
  • Performing on-site/remote audits
  • Managing contracts (creating, revising, maintaining Quality Assurance Agreements, Wholesale Quality Agreements, etc.) and budget with local quality vendors
  • Raising vendor Change Controls in the company system.
  • Responsible for training new hires onboarded into the Supplier Management team
• Internal Audit Program
  • Overseeing the internal audit program
  • Owning the internal audit schedule
  • Performing internal audits
  • Main contact for corporate audits
• Inspections
  • Lead local contact for authority inspections, supporting all Merz sites globally with any requests for information from an authority inspection
• 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.)
  • Authoring/reviewing SOPs
  • Contributing to Quality Management Reviews and quality team meetings
  • Collaborating with local and global quality, safety, regulatory teams
  • Participating in cross-functional projects, driving quality improvement activities, building a company culture of quality through training and quality initiatives
  • Maintaining compliance with Global Therapeutics Quality Management Systems

• 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 and Certifications

• Bachelor's degree in a Scientific discipline (Health Science, Science, Biology, Chemistry, Pharmacy, or related field) is required.
• Quality Auditor Certification is required.

Professional Experience

• At least 6-9 years of drug pharmaceutical quality assurance experience in a role directly involved with supplier auditing.
• Experience conducting pharmaceutical supplier (CMOs, 3PLs, laboratories, etc.) audits as a lead auditor is required.
• Experience hosting or participating in at least one authority inspection as a subject matter expert is required.
• Well versed in auditing principles and audit report writing.
• 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 issuing a supplier corrective action (SCAR) along with follow-up and closeout is considered an asset.
• Knowledge of GMP, US Food and Drug Regulations, ISO 9001 required.
• Prior experience utilizing SAP or another ERP system for supplier management is considered an asset.
• Prior experience using an electronic quality management system such as JIRA, Master Control, Veeva, etc. is considered an asset.
• This role is hiring for a manager of a process—no previous people managerial experience is required.

Knowledge, Skills, and Abilities

• It is required that the candidate is well versed in drug GMP regulations. 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.
• The candidate is able to juggle multiple items at once and is good at prioritizing activities.
• 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 requires routine travel that will include overnight stays. The incumbent will be expected to travel within the USA and Canada, auditing supplier locations on-site. At least one trip is expected/anticipated to be quartely.

• There may be a trip to the German headquarters once every other year.

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.