Manager, Quality Assurance

Alternative Resources Company

Manager, Quality Assurance

Manager, Quality Assurance
 
The Quality Assurance (QA) Manager will hold a key position in our Science and Technology Department. This individual will support existing products and new product introductions by providing and applying Quality Assurance and cGMP expertise for OTC drug products (monographed and NDA/ANDA), medical devices, dietary supplements, and cosmetics.  The individual will also ensure GMP compliance of third-party contract manufacturers (Contractors) by developing and executing the company’s Quality Assurance programs. The individual must develop and maintain an effective working relationship with QA personnel at Contractors and internal stakeholders such as Regulatory Affairs, Strategic Sourcing, New Product Development, Package Development, Supply Planning, and Logistics.
 
Responsibilities
  • 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
  • Achieves QA operational objectives by acting as the point of contact for Quality matters for assigned brands and/or Contractors.
  • Determines QA strategy for assigned brands by studying product requirements; analyzing options for product stability and process validation; recommending, preparing, and presenting corrective action plans; contributing information and opinion to cross-functional teams; preparing implementation plans and timelines.
  • Supports new product introductions from a quality perspective. Reviews and approves documentation associated with the introduction or transfer of a new or existing product to 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.  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, nonconformances, 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, Nonconformance Reports, Deviations, Investigations, CAPA for Annual Product Reviews.
  • Protects organization's competitiveness by keeping information confidential.
  • Maintains professional and technical knowledge by tracking national and international regulatory/governmental 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.
 
Qualifications
  • BS in a Scientific discipline
  • 5 years QA experience in pharmaceutical industry (OTC preferred) with a thorough knowledge of Quality Systems, Quality Assurance, and Quality Control in a cGMP environment
  • Experience with leading and managing cGMP audits
  • Demonstrated sound decision-making process and scientific problem-solving capabilities based on facts, data, and the application of risk management principles
  • Proven track record of managing multiple responsibilities with a consistent sense of urgency
  • Experience with SAP or other similar ERP systems
  • Ability to work independently with a high sense of urgency
  • Ability to analyze information
  • Outstanding verbal and written communication skills and demonstrated interpersonal skills
  • High proficiency in computer skills, Microsoft Office/Project
  • Travel: 20%