A growing pharmaceutical organization is urgently hiring for a QA leader with extensive hands on experience with Quality Systems and Compliance.
Key Responsibilities:
- Lead the development, implementation, and management of the organization’s compliance program.
- Track and respond to changes in regulatory requirements, updating the compliance program as needed.
- Oversee the effectiveness and upkeep of operational and quality-related systems and procedures.
- Drive continuous improvement of Quality systems and practices in alignment with cGMP regulations and regulatory standards.
- Identify and address compliance risks across various functional areas and systems.
- Design and deliver compliance training programs for employees at all organizational levels.
- Ensure adherence to relevant regulations and guidelines, providing senior management with compliance-related insights and recommendations.
- Implement and manage quarterly reviews of compliance systems, recommending corrective actions where necessary.
- Actively engage in Quality Management Reviews.
- Develop and maintain an internal auditing program (self-inspection) in line with cGMP standards.
- Collaborate with departments such as Research and Development, Engineering, Technical Services, Manufacturing, and Quality to create and refine processes related to cGMP compliance.
- Offer compliance-related guidance and support to staff.
- Contribute to vendor development and qualification efforts; audit vendors (e.g., raw materials, packaging, contract labs) to ensure cGMP compliance.
- Investigate reports of noncompliance and work with appropriate teams, including HR, to ensure consistent enforcement of compliance-related actions.
- Maintain a database of FDA 483 observations and Warning Letters, using them as training tools to educate employees on best practices.
- Apply current regulatory knowledge to manage inspections and ensure adherence to applicable regulations, which may involve recommending costly changes to processes, equipment, or systems when necessary.
Key Qualifications:
- Over 7 years of QA experience in the pharma/biopharma industry.
- Hands on experience with Quality Systems and Compliance is a must.
- Must have prior experience managing inspection readiness activities.
- Auditing is experience is required.
- Prior leadership experience is required.
- Hands on experience and knowledge of TrackWise is ideal.
