Our Senior Manager, Quality Assurance supervises the day-to day activities of our QA team members who are supporting existing products and new product introductions by providing and applying Quality Assurance and cGMP expertise for our OTC drug products (monographed and NDA/ANDA), medical devices, dietary supplements, and cosmetics. This individual also ensures GMP compliance of our third-party contract manufacturers by executing our quality assurance programs. This person develops and maintains effective working relationships with QA personnel at contractors and also our internal stakeholders such as regulatory affairs, strategic sourcing, new product development, medical affairs, package development, supply planning, and logistics.
- Foster close cooperative relationships with all functions in the company relative to quality and GMP compliance.
- Achieve QA operational objectives by acting as the point of contact for quality matters for assigned brands and/or contractors and provide direct supervision to other QA team members.
- Determines QA strategy for assigned brands by studying product requirements; identifying quality concerns; analyzing options for product stability and process validation; recommending, preparing, and presenting corrective action plans; contributing information and opinions to cross-functional teams; preparing implementation plans and timelines.
- Supports new product introductions from an operational perspective. Reviews and approves documentation associated with the introduction or transfer of a new or existing product to a contractor. These include but are not limited to stability protocols, laboratory methods, master batch records, product specifications, method validations, process/packaging and cleaning validation protocols and reports. Ensures that product dossiers are maintained and current.
- Evaluates the effectiveness of contractors’ quality systems by leading effective audits for cGMP compliance, issuing audit reports, managing Contractor response adequacy and timeliness; determining system improvements. Escalates all serious cGMP and regulatory compliance issues to department leadership in real time. Coaches contractors where quality systems are deficient; drives remedial action where necessary.
- Defines the quality obligations and responsibilities of contractors by preparing, negotiating, and reviewing quality agreements.
- Assures the quality of commercial product by reviewing and approving contractors’ change controls, deviations, non-conformances, and out of specification investigations. Initiates and conducts internal change controls, planned deviations, and investigations where applicable.
- Prepares reports by collecting, analyzing, and summarizing regulatory and compliance data and trends such as stability, complaints, non-conformance reports, deviations, investigations, recalls, CAPA for annual product reviews.
- Protects organization's competitiveness by keeping information confidential.
- Maintains professional and technical knowledge by tracking national and international regulatory/quality developments; attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
- Accomplishes organization goals by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
- Bachelor's Degree in Scientific or health related field; and not less than 10 years QA experience in pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance, and Quality Control in a cGMP environment; or equivalent combination of experience and training that demonstrates proficiencies in this role.:
- Minimum ability to manage & mentor members of the quality team
- Experience with leading and managing cGMP audits.
- Certified Quality Auditor Certification (CQAR) a plus
- Proven track record of managing multiple responsibilities with sense of urgency
- Experience with SAP or other similar ERP systems
- Demonstrated sound decision making process and scientific problem solving capabilities based on facts, data, and the application of risk management principles
- Ability to multitask and manage projects simultaneously
- Ability to work independently
- Ability to analyze information
- Outstanding verbal and written communication skills
- Demonstrated interpersonal skills
- High proficiency in computer skills, Microsoft Office
Travel: 20% ability to travel via car, plane, rail. Requires valid driver's license and passport