Responsible for the Quality oversight of assigned projects and the various activities in the disposition of commercial product contract manufactured and contract packaged for TherapeuticsMD. Responsibilities include but are not limited to auditing of all production and quality control operations for compliance with current Good Manufacturing Practices, maintenance of Quality Systems including Labeling, Deviations, Laboratory Investigations, CAPA, Documentation, Change Control, Supplier Quality, reporting of quality metrics etc. Acts as the liaison with contract manufacturers and packagers for Quality related activities.Essential Duties and Responsibilities· Assure that development activities including characterization, stability, process optimization, and validation are performed according to regulatory expectations appropriate for the phase of product development.· Oversee the setting of specifications and manufacturing change control processes.· Investigate and address identified compliance and quality issues and develop solutions to correct known and potential compliance and quality concerns at contract manufacturers and packagers.· Conduct and/or coordinate onsite inspections of contract manufacturers and packagers to confirm vendors are following cGMP, regulatory compliance, and TherapeuticsMD specific requirements and SOPs.· Review and perform quality control checks of GMP and CMC documents in support of regulatory filings.· Review and approve master batch records, master labeling/packaging records, product specifications and other process related documents from contract sites.· Perform batch release through batch record and data review/approval and managing process deviations for timely release of finished goods.· Review and/or approve deviations, OOSs, CAPAs, change control in an efficient manner for adequate and timely closeout of these events· Maintain the vendor qualification program through timely audits and follow-up action.· Write, revise and periodically review SOPs to further develop the Quality System and control over the quality of vendor services and products· Review and approve manufacturing validation protocols and reports.· As appropriate, attend project meetings and provide commercial quality input and lead the resolution of commercial quality-related issues· Clearly communicate issues to vendors and company management in a timely basis· Provide commercial quality assurance leadership, guidance, and direction to CMOs consistent with cGMPs and TherapeuticsMD quality principles.Other DutiesOther duties, responsibilities and activities may be assigned.QualificationsRequired Qualifications:· 9+ years’ experience in the pharmaceutical manufacturing industry with at least 5 of those years at Senior Quality Assurance level.· Ability to work in a regulated GMP environment with a strong attention to detail and high degree of accuracy.· Self-motivation, flexibility, and outstanding written and verbal communications skills mandatory. Independently manage and prioritize assigned tasks to meet project deadlines.· Able to transition from task to task and change focus quickly. Capability to adapt to varying requirements from different third party vendors.· Must be able to work effectively within a team environment (independently and collaboratively).· Knowledge of current GMPs and related regulatory health authority guidance (FDA regulations, ICH guidelines, etc.) as they relate to the pharmaceutical industry.· Competency in MS Office Products and Adobe Acrobat· Able to work a flexible work schedule to accommodate program priorities and international activities as neededPreferred Qualifications· Relevant ASQ certifications (auditing or quality management)· Dietary supplement industry experienceEducationBachelor’s degree in a scientific field of study (Life Sciences or Chemistry preferred)Physical functions· The employee is occasionally required to sit, climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 15 pounds and occasionally lift and/or move up to 35 pounds.· Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.Work Environment· This job operates in a professional office environment.· This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.· Some of the work will require exposure to loud noises or fumes in a manufacturing plant environment.TravelThis position requires up to 40% travel (including). Travel includes out of the area, overnight and international.Direct reports As assigned.
Important Safety Tips: You should find out as much as you can about the company. Meet your prospective employers/employees face to face. You should NOT have to provide your bank account details. Stay safe - read our safety tips.