Our client is currently recruiting a QA Manager to provide leadership and energy to its Quality Assurance team. This is an exceptional opportunity to join a corporate culture that is known for having an innovative and growth oriented vision. Responsibilities include:
1) Ensure full quality and regulatory compliance of a facility, while driving process effectiveness and efficiency at the site
2) Ensure site audit readiness and host the quality system audits, prepare and execute quality management system reviews
3) Maintain positive agency relationships-liaisons with regulatory agencies upon site inspections and participates in external technical forums
4) Perform inspection of drug product rejects/complaint investigation samples as part of QA investigations
5) Collaborate with internal departments and across sites to ensure understanding of operating standards and execute requirements of quality system processes
6) Represent quality assurance on multidisciplinary project teams as assigned
7) Contribute to process improvement initiatives across organization - provide support and direction to maintain quality system to recognized standards - direct and/or participate in development of QA processes and SOPs
8) Assist in development of guidelines and standards on an international level
9) Lead and participate in quality improvement projects
10) Evaluate existing QA policies and procedures and make changes where applicable
11) Plan, prepare and perform internal and external system audits as well as study-related audits
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1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the pharmaceutical industry is strongly preferred
4) Preference will be given to people who have recent experience in quality assurance
This position is critical to the team and requires a qualified individual to fill the role... someone with a real go-getter attitude!
Sterling-Hoffman Life Sciences is the premier recruitment firm in North America for companies involved in the research, clinical development, manufacturing and distribution of drugs and devices that allow patients to live healthier and more fulfilling lives. Leveraging a network of relationships in every major city – including New York, San Francisco, Raleigh-Durham, Chicago, Dallas, Denver and Los Angeles – Sterling-Hoffman Life Sciences is ideally positioned to assist fast growing CROs, pharmaceutical companies, biotech firms and medical device players in their quest to recruit the best people.