The Senior Compliance Manager will provide direction for the development, execution, and compliance of the Company’s Quality Assurance program to comply with all appropriate quality regulations. The position is responsible for internal and external auditing and reporting on the management and/or performance of all GMP, GLP, GCP (GXP) QA functions. This position supports Invicro’s QA program, which is imperative to ensure adherence to federal, state and international regulations and standards.
- Assist with inspection readiness, and regulatory inspections as needed
- Hosts and/or supports customer audits and ensures appropriate and sustainable action plans are developed and implemented.
- Oversee the audit response and ensure acceptability of actions to address findings through the CAPA process
- Conduct and/or assist in internal audits (systems, processes, vendors, computer system validation)
- Interact with contract auditors in the scheduling process, kick-off meetings with auditors and internal groups, assist in the drafting of audit plans, confirmation letters and agendas, etc.
- Experience in vendor management (min. 5 years’ experience preferred)
- Perform audits and help manage the qualification of external vendors to ensure compliance with applicable regulations and standards.
- Draft, review or revise SOPs to assess consistency and compliance with regulatory requirements/internal standards
- Attend cross-functional team meetings and provide guidance to staff based on interpretation of current regulations to ensure best practices including risk-based management
- Perform root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements to functional and senior management
- Work with the Director of Compliance to serve as a back-up and to help manage the Quality Management System and related processes.
- Work with QA leadership to provide training, knowledge management, and strategic quality consultation to internal and external customers as needed.
- A well organized, self-motivated and independent work style with the ability to initiate and follow through on assignments
- Excellent interpersonal skills with knowledge of basic negotiation, influencing and conflict management to assure effective interactions within and across departments
- The ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
- A strong team player is required with the ability to effectively communicate sound Quality advice cross-functionally based on experience, regulations & business needs
- Experience with using risk-based principles & decision making to ensure compliance at all stages of development
- Proven track-record of leadership & building relationships with both internal & external customers
- Effective communication and organizational skills
- Strong oral and written skills
- Bachelors level degree in a scientific or life sciences discipline
- A minimum of 5+ years of relevant and increasingly responsible experience in the Biotech/Pharmaceutical Industry in a GCP quality role and compliance
- CQA, or equivalent, certification preferred
- 3-5 years management experience preferred
Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.