|Title:||Associate Director/ Senior Manager, Quality Assurance- GCP|
|Job Status:||Full-time, Benefited|
Oversee, assess and assure compliance of Celerion Early Clinical Research (ECR), and Drug Development Services (DDS) lines of service and their processes with applicable regulations and guidelines (US and international) on a global level. Serve as GCP compliance point of contact globally for all Celerion clinical site and QA staff. Deputy to the Executive Director, Head of Global Quality Assurance.
Essential Functions (Includes percentage of time after each function):
QA Staff Leadership and Management (25%)
- Oversee and manage on –site and remote QA staff management in accordance with the organization's policies/procedures and all applicable regulations/laws/guidance documents. Responsibilities include interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; development and coaching of employees.
- Actively assist in QA departmental budget preparation, oversight, administration, review and containment.
- Actively assist in defining QA company strategy aligned with business and regulatory objectives.
- Develop, revise and implement QA SOPs/PGs/IKRs
Global GCP Compliance (25%)
- Oversee global GCP compliance and serve as expert/point of contact for regulatory compliance topics, including but not limited to the following: SOP/PG/IKR review, process improvement identification and project leadership/participation, Sponsor/Celerion Transfer of Regulatory Obligations documents (TOROs) and internal clinical site consultant.
- Design and deliver regulatory trainings and workshops to QA and operations staff.
- Lead, conduct and develop reports for internal investigations resulting from potential research misconduct.
- Review Major deviations for ECR, DDS, QA, and cross functional lines of service (LOS) and assure that any resulting QIs/CAPAs are logged as appropriate
Client Audits and Regulatory Authority Inspections/Certifications (10%)
- Oversee, manage/facilitate and provide subject matter support to ECR/DDS QA for client audits and regulatory authority inspections/certifications globally.
- Oversee and serve as subject matter expert for GCP client and regulatory authority observation responses for all Celerion clinical sites (ECR) and DDS LOS.
- Manage/lead application process, as necessary, for regulatory authority certifications.
Internal and Vendor Audit Programs (20%)
- Oversee, manage and carry out GCP facilities/systems and study/project audits for all Celerion clinical sites (ECR), DDS, QA and other cross functional LOS, as necessary.
- Oversee, manage and carry out comprehensive GCP/GLP vendor audits globally.
Quality Management System and Continuous Process Improvement (20%)
- Serve as the Quality Lead on Quality Issue Resolution Teams (QIRT) for Clinical (ECR), DDS and cross LOS meetings.
- Actively participate in the Customer Complaint process. Assure that any resulting QIs/CAPAs are logged as appropriate.
- Oversee and manage the QI/CAPA process. Identify/detect QIs and assess the need for CAPA. Serve as quality partner on QI/CAPAs. Assure that corrective and preventative actions are taken/documented as necessary.
- Manage and lead improvement initiatives intended to improve GCP compliance of Celerion processes and sites.
- Manage, design and develop metrics collection tools for QA quality indicators across all LOS.
- Manage and actively participate in quality metrics collection, analysis, and presentation for Local and Global Quality Councils.
- Bachelors degree in science, business, or similar
- Minimum of 10 years QA / compliance experience required
- Minimum of 5 years management experience required
- Working knowledge of GxPs (GCP, GLP, cGMP, GVP and GDP) (US and international)
- Excellent oral and written communication skills
- Ability to organize and manage multiple priorities
- Excellent time/resource management skills
- Attention to detail, tactful, and diplomatic, computer literate.
*Equivalent education and experience will be considered.