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.