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Job Title: Corporate Compliance Director
Location: California, Fremont
Discipline: Quality
Reference: DMMD7281
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Description: Directorship-Senior/Medical Devices and Diagnostics / healthcare industry
DMMD7281
Corporate Compliance Director
International Reach
Fremont, CA
The Corporate Compliance Director provides leadership to global organization
responsible for establishing and maintaining the global compliance program
to ensure compliance to regulatory, international standards, company
policies and procedures and corporate requirements. Provide direction
to the global compliance group in the management of regulatory inspections
(internal and external) and related compliance activities. Establish and
maintain programs that ensure the verification and monitoring of the
effectiveness of the company quality system and its compliance to applicable
regulations and standards. Ensure results of monitoring process are
routinely communicated to Management through Management Review process.
Oversee the escalation of product quality issues to the Quality Board
ensuring decisions are reached in a timely manner and follow and established
process for decision-making and documentation. Maintain the recall
management process ensuring actions are made in a timely manner and status
updates are provided on a routine basis both internally and externally.
Support all compliance activities in all regions where product is evaluated,
developed, manufactured, marketed, distributed and monitored through
post-market surveillance programs. Monitor the external environment to
identify new or emerging regulations and determine the impact and
implementation plan into product's quality system.
Qualifications: Minimum Qualifications
Bachelor degree within Engineering, Science, Business Quality or equivalent
discipline is required. Graduate degree in related disciple is preferred.
12 years Quality Assurance, Compliance, Quality Systems experience is
required. 7 or more years of leadership experience in Compliance,
Quality Assurance or Quality Systems within a Medical Devices and
Diagnostics or other regulated healthcare industry is required. 7 plus
years of people management experience is required. Managing international
direct reports is highly preferred. Extensive knowledge of FDA Quality
System Regulations, ISO 13485 Standard and International regulations are
required. Demonstrated knowledge of supply chain, clinical and research &
development operations as it relates to the medical device industry is
required. Previous experience demonstrating the ability to influence and
enroll business partners in the development and sustainability of the
Quality System and compliance program is required. Over 7 years of lead
auditing experience during Compliance audits with FDA, Notified Bodies and
international regulatory authorities is required.
Travel 40% of domestic and international required.
Certifications in Process Excellence and/or ASQ certification
(i.e. CQA, CQE, etc) are assets.
Apply to: Click Here
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