Senior Compliance Auditor
Job Title : Senior Compliance Auditor
Direct Hire
Hybrid (Cambridge onsite Monday, Tuesday, Thursday)
Vaccination Requirements : no
Must Haves :
- Basic knowledge of GMP regulations.
- Experience with electronic Quality Management Systems.
- Expert knowledge of GMP, QSR regulations.
Preferred :
Experience with EN ISO 13485 - medical device industry's quality management system (QMS) harmonized standard
POSITION SUMMARY
This position is responsible for leading / participating in and reporting of internal and external audits. Ensures current Quality Technical Agreements with critical suppliers and service providers.
DUTIES AND RESPONSIBILITIES
Essential Functions :
- Accountable for project completions and achievement of compliance goals.
- Perform internal audits to ensure compliance to applicable regulations such as GMPs, 820 and company requirements.
- Lead and support supplier and service provider audits (onsite and paper questionnaires) to ensure compliance with GMPs, applicable regulatory requirements and requirements.
- Support the company Supplier Management Program, including the drafting and maintenance of Quality Technical Agreements, where required.
- Address and / or escalate compliance problems and issues to the Supplier Management Team (SMT) for supplier issues and Quality Management for internal issues.
- Provide support to the SMT through meeting participation and discussions.
- Provide support to medical device suppliers (CMO) project teams for issue resolution or questions.
- Provide and / or revise Standard Operating Procedures.
Leadership Responsibilities :
Understanding, observing, and adhering to the goals and policies outlined in the Code of Business Conduct and Ethics
- Being honest and treating people with respect and courtesy.
- Constantly striving to make this a great place to work, and a company respected for the quality of its people and products.
- Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
Basic Qualifications :
- Bachelor's degree or equivalent with 15 years of experience in a quality unit within the pharmaceutical / biotech industry.
- Five years of experience auditing as a qualified auditor of suppliers for compliance with cGMP, QSR and ICH regulations.
- Knowledge of relevant FDA regulations / guidance and ICH Guidelines.
- Ability to plan / execute and report audits independently.
- Experience in cell manufacturing / biologics, medical devices, and / or software quality.
- Exposure to Good Clinical Practice (GCP) and ICH E6.
Preferred Qualifications :
- Basic knowledge of GMP regulations.
- Experience with electronic Quality Management Systems.
- Expert knowledge of GMP, QSR regulations.
- Proficient in MS Office.
- Strong communication, organization and time management skills.
Senior Compliance Auditor
Job Title: Senior Compliance Auditor. Five years of experience auditing as a qualified auditor of suppliers for compliance with cGMP, QSR and ICH regulations. Accountable for project completions and achievement of compliance goals. Perform internal audits to ensure compliance to applicable regulatio...
Senior Compliance Auditor
Five years of experience auditing as a qualified auditor of suppliers for compliance with cGMP, QSR and ICH regulations. Accountable for project completions and achievement of compliance goals. Perform internal audits to ensure Vericel compliance to applicable regulations such as GMPs, 820 and Veric...
Senior Compliance Auditor
Job Title: Senior Compliance Auditor. Five years of experience auditing as a qualified auditor of suppliers for compliance with cGMP, QSR and ICH regulations. Accountable for project completions and achievement of compliance goals. Perform internal audits to ensure compliance to applicable regulatio...
Senior Quality and Compliance Specialist (GCP Auditor)
Assists in other duties relating to overall compliance within Quality and Compliance department, as requested. Job Specific Skills: Maintains a strong understanding of regulations and guidance as they pertain to compliance; maintains knowledge relating to regulatory updates. Clinical Research Coordi...
Compliance Clinical Senior Auditor
The Senior Clinical Compliance Auditor is responsible for developing, auditing plans, and collaborating with Operations and Revenue Cycle in auditing/monitoring compliance requirements across all Company business units and service lines. Assists with the day-to-day compliance and auditing including ...
Senior Quality and Compliance Specialist (GCP Auditor)
Assists in other duties relating to overall compliance within Quality and Compliance department, as requested. Maintains a strong understanding of regulations and guidance as they pertain to compliance; maintains knowledge relating to regulatory updates. Clinical Research Coordinator, Clinical Resea...
Compliance Senior Auditor
The Senior Compliance Auditor is responsible for developing, auditing plans, and auditing/monitoring compliance requirements across all Company business units and service lines. Collaborates with Ethics and Compliance Officers to contribute to projects related to the Compliance Audit, Self-Monitorin...
Senior Healthcare Compliance Auditor (Client Facing) - Remote in MA
Senior Healthcare Compliance Auditor. Ensure adherence to state and federal compliance policies, reimbursement policies, and contract compliance. Must have the following: Certified Coder, Certified Auditor, Registered Nurse, OR Licensed Practical Nurse. ...
Accountant/Senior Audit
The Accountant/Senior Audit performs field audits and provides support for customers. This Accountant/Senior Audit role also assist with the development, training, and supervision of Staff Accountants and Interns. Responsibilities of the Accountant/Senior Audit:. Qualifications for the Accountant/Se...
Compliance Analyst
The primary role of this position is to support TCB's Compliance team in its efforts to help ensure affordable housing program(s) and TCB Operations policy compliance. Assist in the monitoring of compliance team mailbox and the prompt dissemination of information to appropriate parties including mem...