Manager
Corporate Compliance
Location:
Northeast
Responsibilities:
Schedule and lead Corporate audits of all
Corporate facilities to assess compliance with corporate policies and GMP/ISO/IDE
regulations.
Assist in developing corrective action plans
to assist facilities in achieving compliance.
Manage and direct a staff of Senior
Compliance Specialists.
Develop and maintain audit program that
incorporates the proposed changes in the
GMP/QSR/ISO regulations.
Schedule and conduct audits of specific
areas, products, or processes as requested.
Participate with Corporate and divisional QA
personnel on policy/procedure/ guideline development.
Qualifications and Requirements:
Minimum of 5 years Managing/Supervising
experience in a Compliance Auditing capacity in a
pharmaceutical or medical device
environment.
Comprehensive knowledge of FDA/ISO
regulations and guidelines, to include GMP/QSR,
MDR, IDE, MDD, and EN standards.
Experience with the requirements of Design
Dossiers and Technical Files.
Experience participating in audits from
external auditors such as FDA, ISO and MDD.
BS in a life science or related field.
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