** This role is onsite in Raleigh office 3 days a week and 2 remote **
Who We Are: Harvesting Hope with a Growing Family
At Merz Therapeutics, we take a nurturing approach to our organization - treating colleagues like family, embracing our whole selves and creating a company culture that encourages growth and decisive action. We are committed to caring for whole communities by focusing on individuals suffering from movement disorders and neurological conditions and the healthcare providers dedicated to helping them, while simultaneously bolstering our team members in a united effort to make a difference.
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 and 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! #IAmMerzTx
Merz Therapeutics is seeking a Manager, Quality Assurance.
This role will be the local Quality Management System representative and be responsible for development and oversight of Supplier Management 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.
Essential Duties and Responsibilities
Local Quality Assurance

• Contributing to the development and operations of the Quality Management System requirements for Merz Therapeutics U.S. within Global therapeutics Quality Management System
• Responsible for contributing to local Quality Management Reviews and writing the Annual Quality Management Report
• Working with regulatory officials during local quality inspections and supporting all Merz sites globally with any requests for information from an authority inspection
• Local lead for Merz Therapeutics U.S. and Canadian recall activities (process, communication, reporting)
• Managing contracts and budget with local quality vendors
• Lead local contact for internal corporate audits and authority inspections
• Overseeing Supplier Management program through supplier qualification activities, supplier audits, maintaining contracts, monitoring performance and maintaining the audit schedule
• Monitoring, tracking and investigating deviations
• Corrective and Preventive Action (CAPA) activity implementation, reporting, and close out
• Building a company culture of quality through training, quality initiatives
• Driving quality improvement activities
• Creating, revising, maintaining Quality Assurance Agreements
• Creating work processes for local QA and writing corresponding SOPs.
• Provides local QA oversight for GXP systems and applies risk-based methodology to validation/qualification efforts
• Provide quality assurance oversight for production, testing and release of packaging activities at 3PL vendor(s)
• Provide quality assurance oversight for distribution of products in North America

Global Quality Assurance Collaboration

• Responsible for maintaining compliance with Global Therapeutics Quality Management System
• Participating in internal auditing system by global quality assurance
• Liaison to Global Quality functions, ensuring local compliance to global requirements and ensuring consideration for local requirements within global system
• Participate in cross-functional project teams, when appropriate
• Managing collaborative relationship with Global therapeutics R&D, Global Technical Operations and Global Aesthetics Quality Management team

Other duties as assigned

• Supporting local leadership in any safety/quality objectives as applicable
• Staying up-to-date on all SOP reading/training requirements
• Notify manager of regulatory compliance questions and issues
• Backup to team members as needed including technical complaint management, Document control activities, training, etc.

Job related qualifications/Skills
Education
Bachelor's degree (Health Sciences, Science, Biology, Chemistry, Nursing, Pharmacy or related field) Required
Professional experience

• Minimum of 8 years of experience in the pharmaceutical or biotechnology industry with at least 5 of those years in QA or closely related field Required
• Experience conducting internal and/or supplier audits as a lead auditor Required
• Experience performing formal drug product release for market distribution Preferred
• Experience working in and with different people and organizational cultures, supporting people with diverse backgrounds, attitudes and cultural differences Preferred
• Experience hosting or contributing to authority GMP inspections Required
• Certification as a Quality Auditor Required

Knowledge, skills and abilities (incl. languages)

• Thorough understanding of quality assurance and ability to communicate with Regulatory and Quality personnel Required
• Must be proficient in Microsoft Office applications including Word, Excel and PowerPoint Preferred

Knowledge of methods

• Working knowledge of GMP, US Food and Drug Regulations, including biologics Required

Personal skills

• Strong interpersonal and team collaboration skills Required
• Excellent verbal and written communication skills. Ability to clearly articulate quality concepts Preferred
• Strong multi-tasking, time management, and organizational skills Preferred

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.
Recruitment Note:
Merz Therapeutics only sends emails from verified "merz.com" addresses and never asks for sensitive, personal information or money. If you have any doubts about the authenticity of any type of communication from, or on behalf of Merz Therapeutics, please contact Therapeutics.HR@merz.com