Quality Assurance Technical Lead

Job Title: Quality Assurance Technical LeadReporting To: NA Quality ManagerLocation: Hybrid role with preference to candidates in Cary, NC, but willing to consider remote individual having key experience.Job Purpose: In close partnership with Operations, R&D, Commercial and the rest of Scientific Affairs, and under the guidance of the North American Quality Manager, this role provides hands-on quality assurance support for a range of consumer healthcare products (dietary supplements, OTC Class 1 medical devices, and homeopathic drugs) that Alliance Pharma Inc. distributes in North America (70%).This role is also responsible for the day-to-day activities to ensure successful technical product transfers based on the strategy set by the North American Technical Manager (30%). This is a new, key role within the North American Scientific Affairs team at Alliance.Key Responsibilities:Support North American QA by owning and conducting specific QA activities defined in corporate and regional standard operating procedures, under the direction of the North American Quality Manager, with minimal oversight.Ensure that products are released per documented specifications, including oversight of QA functions performed by contracted partners and formal release activities performed by Alliance personnel as defined by procedure.Manage nonconformance and deviations, including initial impact assessment, root cause analysis, and corrective and prevention, as well as documentation, under the oversight of the QA Manager.Write and maintain Standard Operating Procedures and conduct trainings, as assigned.Perform other QA-related duties as assigned and as related to corporate growth and acquisitions.Execute assigned technical projects, alongside cross-functional teams and external partners, as required, to facilitate communications and be responsible for delivering on technical projects to plan, quality and cost, under the guidance of the NA Technical Manager.Manager the day-to-day activities of technical product transfers to ensure the successful transfer of product manufacturing from one CMO to another, under the strategies set by the NA Technical Manager. This includes but is not limited to overseeing the execution of stability and validation programs, as agreed to with CMOs and 3rd party laboratories.Create and maintain product specifications for new and existing products.Perform other technical-related tasks, as assigned.Essential Requirements:Bachelor's degree from an accredited college/university. Preferably in a scientific or technical field.Minimum of 3-5 years working with FDA-regulated consumer products (dietary supplements, OTC drugs, OTC Class 1 medical devices, cosmetics and/or food) in a Quality Assurance, Technical, R&D role or related function.Understanding of GMP, GLP and/or GCP regulations as they apply to the development and distribution of drugs, medical devices, or dietary supplements in North American markets.Out of the box thinking, ability to solve complex problems and intellectual curiosity are all essential to be successful in this not-so-typical hybrid Quality Assurance/Technical role.An interest in gaining experience in technical projects and innovation.Attention to detail in written, numerical and graphical work.Effective collaborator able to build and sustain good relationships across geographical, cultural, and functional boundaries.Able to understand and implement complex written and verbal instruction, particularly scientific information.Self-motivated and comfortable in a dynamic environment with multiple priorities and able to successfully work in a matrixed organization.Strong written and spoken communication skills.Ability to work effectively in a remote/hybrid environment.Willingness to travel to the Cary, NC office and other domestic travel, as needed (10%).Desirable Qualifications:Auditing experience either as an auditor, attendee or having hosted audits or inspections.ASQ CQA/CQE or equivalent preferred but not a requirement, or interest in pursuing these certifications.Experience managing/leading projects involving cross-functional teams.Ability to influence contract manufacturing partners and cross-functional team to foster open and collaborative discussions to solve problems and find impactful solutions.

Created: 2025-01-16