• Establishes, implements, and maintains quality management system.
• Ensures current quality management policy is in compliance with relevant regulatory agencies following laboratory protocol and procedures.
• Liaison between Manufacturing and QA for executed Batch Record Review and flow of documents.
• Reviews and dispositions production batch records for product release. Determines if records are compliant with internal and cGMP regulations.
• Reviews and approves GMP product labels.
• Supports FDA/Regulatory inspection activities.
• Supports regulatory filing as needed.
• Collects and presents metrics to document performance.
• Train staff as needed.
• Collaborates with other departments to address issues and meet deadlines.
• Participates in and/or lead project teams as a Quality representative.
• Provides support for internal and external audits.
• Influence and implement initiatives within QA to improve overall compliance and maintain inspection readiness.
• Develop, review, and approve protocols/strategies (validation, qualification, commission, etc.)
• Ensuring that the QA department is integrated in project delivery from project initiation to completion.
• Due to the nature of the development process and drugs/medical devices – the company environment is fast paced and constantly changing. The individual will need to have the ability to ensure that prioritizing, allocating and monitoring work across team members to meet customer deadlines is managed appropriately.
• Achieve throughput and turnaround targets on a project, monthly and annual basis, monitoring and reporting on the productivity of the team. Report performance against Key Performance Indicators (KPIs).
• Develop a collaborative, pragmatic culture that encourages colleagues to support each other in problem solving to achieve excellent and timely results for customers
• Perform other duties as required.

• BS/BA in Life Science (Biology or Biochemistry) or Equivalent
• Minimum 6 years pharmaceutical experience required.
• Minimum 6 years’ experience in Quality Assurance Management required.

• Extensive knowledge of FDA regulatory requirements applicable to pharmaceuticals. Ability to apply GMP regulations guidelines to all aspects of the position.
• Technical knowledge of pharmaceutical manufacturing, validation, raw materials, analytical testing, and materials management is desirable.
• Working knowledge of 21 CFR Parts 210, 211 and 820 FDA compliance.
• Audit or inspection experience preferred.
• Excellent communication skills, verbal and written.
• Experience in a business systems analysis role/function for QA.
• Knowledge of cGMP regulations applicable to the U.S.A.
• Demonstrated ability to manage multiple activities while maintaining a high level of organization.
• Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
• Familiarity with Microsoft Project and project management principles.
• Able to work effectively in a customer service and business partner role.
• Ability to anticipate problems before they become critical and involve management when appropriate.
• Ability to work as part of a team and collaborate effectively with staff at all levels.
• Ability to work independently in achieving goals and objectives.

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