US-NorthCarolina-Charlotte: Director of Corporate Quality
To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99666338_Director_of_Corporate_Quality.htmlTo see other opportunities, please visit
http://sqa.fyicenter.comDate: 03-Nov-2011
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.
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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