Director, Operational Quality Management
The Director, Operational QA is responsible for managing all aspect of Operational Quality Assurance. Continually works to improve the effectiveness of QMS through the effective application of quality policies, objectives, audit results, analyses of data, and corrective/preventive actions This includes the management of individual teams responsible for the execution of the Internal/Vendor Audit Program, External Audit hosting, Training Coordination, Designated Complaint Unit and GCP Compliance. Is responsible for interfacing with the Directors, Product QA and Director, QA/RA (Strategic QM) to generate and evaluate QM metrics, define and initiate new Quality Strategies.
Essential Duties and Responsibilities:
- Establish and maintain all Operational aspects of the ERT Quality Management System in accordance with GxP (specifically GCP and GMP) and relevant local and international standards. Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints.
- Manages and drives accountability of a diversified team of Quality professionals responsible for leading individual teams focused on specific Quality initiatives including but not limited to: Internal/Vendor auditing, hosting External audits of ERT, execution of the Designated Complaint Unit (DCU), employee training programs and controlled document management and the GCP Compliance leader.
- Provides regular, routine and timely performance-related feedback (up to and including formal performance evaluations, as required by HR) to ensure positive employee development and performance to company, quality and behavior goals and standards.
- Routine collaboration with the Directors, Product QA and Director, Quality Assurance/Regulatory Affairs to identify and prioritize Operational QA initiatives.
- Prepares quality documentation, metrics and reports by collecting, analyzing and summarizing information and trends including failed processes, individual study performance, Root Cause/CAPA activities, etc.
- Continually works to improve the effectiveness of QMS through the effective application of quality policies, objectives, audit results, analyses of data, and corrective/preventive actions.
- Responsible for keeping abreast of GxP rules/regulatory changes that may have an impact on ERT and works to mitigate any possible risk related to such changes.
Other Duties and Responsibilities:
- Manage, direct, deliver, or ensure delivery of GxP training and orientation to all employees, volunteers, medical and professional staff and applicable business associates.
The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. This job description and any attachments do not constitute or represent a contract.
Qualifications and Skills Needed:
- Minimum 7-10 years relevant experience
- Bachelor’s Degree or equivalent experience
- Strong knowledge of EU General Data Protection Regulation (GDPR) on the protection of individuals with regard to the processing of personal data and on the free movement of such data; EU Model Clauses
- Strong knowledge of HIPAA and other privacy and security laws, regulations, and corresponding practices
- General knowledge of global compliance requirements related to global geographic area – US, EU, APAC, etc.
- Formal education or professional experience in law, privacy, public policy, or health care; Pharmaceutical/Clinical Trial experience preferred.
- Experience working in environments that process personally identifiable information (PII) or protected health information (PHI)
- Experience establishing and maintaining privacy and security compliance in a health-related setting
- Excellent organizational, interpersonal, verbal, and written communication skills
- Ability to work effectively as part of an integrated project team, while also taking ownership of assigned tasks to successfully achieve explicit delivery dates and milestones
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.