US-NorthCarolina-Charlotte: Director of Corporate Quality
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Director of Corporate Quality
• Establish Quality systems, policies, objectives, initiatives and organizational structures that support the organization’s global quality reputation.
• Develop the quality strategic plans, budgets and establish overall departmental goals.
• Create e quality processes and strategies to ensure compliance with all regulatory agencies and improve internal quality practices.
• Develop and implement a robust process for company equipment and process validation requirements.
• Establish and lead the cross functional monthly quality review meetings to ensure effective communication and drive quality improvements throughout the organization.
• Represent corporate management during corporate QA regulatory audits and provide responsive leadership during the course of the audit.
• Oversee preparation, editing, and revisions of standard operating procedures and policies based on needed process improvements and/or changes in regulatory requirements.
• Develop Quality System process improvement initiatives, including automation via MasterControl.
• Develop reporting tools and metrics monitoring the performance of each Quality System. • Evaluate Corporate QA staff performance, and provide development direction to QA staff. • Assume other responsibilities as directed by the Sr. Director, Regulatory Affairs and Quality Assurance.
1. Bachelor's degree in a science related field or equivalent. Advanced certifications recommended.
2. Ten (10) years experience in biotechnology environment with increasing regulatory or quality responsibilities. Blood/plasma donor center experience preferred.
3. Previous experiences should demonstrate extensive knowledge of biologics industry and related procedures, regulations, and standards, as well as quality programs.
4. Self-motivated individual with strong organizational skills and attentiveness to detail.
5. Ability to multi-task while retaining organizational skills to completion.
6. Documented computer software quality assurance skills. 7. Excellent analytical skills.
8. Possess excellent proof-reading skills.
9. Excellent verbal, written, and interpersonal communication skills.
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Team SQAFYI - Software QA Resource FYI