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    Manager, Quality Assurance - Raleigh, United States - Merz Therapeutics

    Merz Therapeutics
    Merz Therapeutics Raleigh, United States

    3 weeks ago

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    Description

    This role is onsite in Raleigh office 3 days a week and 2 remote

    Who We Are:

    Harvesting Hope with a Growing FamilyAt 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 #IAmMerzTxMerz 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 ResponsibilitiesLocal Quality AssuranceContributing to the development and operations of the Quality Management System requirements for Merz Therapeutics U.S.

    within Global therapeutics Quality Management SystemResponsible for contributing to local Quality Management Reviews and writing the Annual Quality Management ReportWorking with regulatory officials during local quality inspections and supporting all Merz sites globally with any requests for information from an authority inspectionLocal lead for Merz Therapeutics U.S.

    and Canadian recall activities (process, communication, reporting)Managing contracts and budget with local quality vendorsLead local contact for internal corporate audits and authority inspectionsOverseeing Supplier Management program through supplier qualification activities, supplier audits, maintaining contracts, monitoring performance and maintaining the audit scheduleMonitoring, tracking and investigating deviationsCorrective and Preventive Action (CAPA) activity implementation, reporting, and close outBuilding a company culture of quality through training, quality initiativesDriving quality improvement activitiesCreating, revising, maintaining Quality Assurance AgreementsCreating work processes for local QA and writing corresponding SOPs.

    Provides local QA oversight for GXP systems and applies risk-based methodology to validation/qualification effortsProvide 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 AmericaGlobal Quality Assurance CollaborationResponsible for maintaining compliance with Global Therapeutics Quality Management SystemParticipating in internal auditing system by global quality assuranceLiaison to Global Quality functions, ensuring local compliance to global requirements and ensuring consideration for local requirements within global systemParticipate in cross-functional project teams, when appropriateManaging collaborative relationship with Global therapeutics R&D, Global Technical Operations and Global Aesthetics Quality Management teamOther duties as assignedSupporting local leadership in any safety/quality objectives as applicableStaying up-to-date on all SOP reading/training requirementsNotify manager of regulatory compliance questions and issuesBackup to team members as needed including technical complaint management, Document control activities, training, etc.

    Job related qualifications/SkillsEducationBachelor's degree (Health Sciences, Science, Biology, Chemistry, Nursing, Pharmacy or related field) Required Professional experienceMinimum of 8+ years of experience in the pharmaceutical or biotechnology industry with at least 5 of those years in QA or closely related field RequiredExperience conducting internal and/or supplier audits as a lead auditor RequiredExperience performing formal drug product release for market distribution PreferredExperience working in and with different people and organizational cultures, supporting people with diverse backgrounds, attitudes and cultural differences PreferredExperience hosting or contributing to authority GMP inspections RequiredCertification as a Quality Auditor RequiredKnowledge, skills and abilities (incl.

    languages)Thorough understanding of quality assurance and ability to communicate with Regulatory and Quality personnel RequiredMust be proficient in Microsoft Office applications including Word, Excel and PowerPoint PreferredKnowledge of methodsWorking knowledge of GMP, US Food and Drug Regulations, including biologics RequiredPersonal skillsStrong interpersonal and team collaboration skills RequiredExcellent verbal and written communication skills.

    Ability to clearly articulate quality concepts PreferredStrong multi-tasking, time management, and organizational skills PreferredDon'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 "" 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.comEqual Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

    However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

    41 CFR c)
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