Quality Assurance Manager, Global Quality (Finance)

Based in the Boston, Massachusetts 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? Major Duties:

• Batch Record Review and Release (Inbrija / (F)Ampyra)
  • Conducts and supports QA review of CGMP-related documentation, such as specifications, test methods, validation protocols and reports, stability protocols and reports, master production records, deviation reports, investigation reports and Out of Specification reports, design history file/medical device file/technical documentation, etc.
• Supplier Maintenance and Requalification (Audit support)
  • Supports the GMP quality management of external commercial manufactures (drug product and medical devices). Conducts and assists in audits in support of the GMP audit function. Evaluates corrective and preventative action responses to audit findings and GMP events for adequacy and timeliness and ensures timely and effective close-out of these actions.
• SOP Authoring/Support
  • Authors and conducts QA review and approval of Standard Operating Procedures and other related documentation, such as forms, work instructions, policies, etc.
• Stability Program Review and Oversight
  • Supports the maintenance and review of the stability program for Inbirja and (F)Ampyra.
• Deviation Review and Approval
  • Demonstrates appropriate quality oversight of root-cause analysis and product impact for product quality investigations as a result of events, ensuring appropriate CAPA actions are identified and addressed
• Change Control Support
  • Supports intiation, review, and mainteannce of change controls, both external (supplier dirven) and internal.
• Documentation Support (QMR, APR, etc.)
  • Author, review, and support relevant sections of periodic quality system monitoring reports including product management review and annual product reviews.
• QMS Maintenance and Metric Support
  • Ensures that metrics and trends as well as compliance issues and their resolution are tracked on a periodic basis and presents metrics and trends during management review meetings. Ensures Quality documentation files, databases and logs are maintained.
• Cross-functional Support to Internal and External Merz Departments
  • Works constructively with all other departments both internally and externally.

Required Qualifications/Skills

• Degree in Biology, Chemistry, or related science
• 5-10 years of experience in the pharmaceutical industry

Preferred Qualifications/Skills

• Experience with solid oral dose and / or pharmaceutical spray drying