Quality Assurance Supervisor - United States
- Supervise and provide support in the management of daily work flow operations of Quality Assurance (QA) staff.
- Ensure staff assignments are in alignment with regulatory inspection and reporting requirements.
- Oversee daily operational activities/schedules and ensure QA resources are properly assigned to manage regulatory oversight.
- Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures.
- Review, revise and approve (GMP QA) SOPs, protocols/batch records, reports, and other quality and regulated records involving technically complex issues and processes for accuracy and compliance with all applicable regulations and internal policies.
- Participate in the preparation and review of study and QA files in preparation for sponsor site visits and regulatory inspections; assure that QA audit files are retained.
- Participate in client site visits and regulatory inspections.
- Participate in the development of recommendations for corrective and preventative actions to respond to client visit and regulatory inspection findings.
- Routinely provide recommendations to Regulatory Affairs and Compliance management for improvements in auditing of Quality Systems based on extensive knowledge and understanding of regulations and quality principles.
- Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures as needed to support departmental workload.
- May participate in inspections and audits of subcontractors, vendors, and suppliers of products and services.
- Assure the suitability of materials and supplies for compliance with specifications (GMP QA).
- Review and approve all procedures related to production and maintenance, approving or rejecting incoming materials, in-process materials and finished product (GMP QA).
- As required, oversee maintenance of group training manual and training records.
- May assist in development of departmental budget.
- Responsible for personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development.
- Support the policy of equal employment opportunity through affirmative action in personnel actions.
- Provide regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews.
- Perform all other related duties as assigned.
- Knowledge of Microsoft Office applications (e.g. Word, Access, Excel).
- Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements.
- Excellent judgment, decision-making, training/mentoring skills and verbal/written communication skills.
- Strong leadership, organizational skills and detail oriented.
- Able to prioritize workload and manage multiple tasks.
Equal Employment Opportunity