Base Salary: Confidential Bonus: Benefits: Other Compensation: A superb base salary and bonus structure are available; compensation is commensurate with experience and will be discussed with qualified candidates only.
Skills and Experience
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Qualifications / Skills Required
1) Bachelor's degree in a science related field or equivalent
2) Advanced certifications (preferred)
3) Minimum 10+ years of experience in biotechnology environment with increasing regulatory or quality responsibilities
4) Blood/plasma donor center experience (preferred)
5) Previous experience should demonstrate extensive knowledge of biologics industry and related procedures, regulations and standards as well as quality programs
6) Ability to multi-task while retaining organizational skills to completion
7) Self-motivated individual with strong organizational skills and attentiveness to detail
8) Computer software and quality assurance skills
9) Excellent analytical skills
10) Possess excellent proof-reading skills
11) Excellent verbal, written and interpersonal communication skills
Job Description
Print Job Description
Partial Job Description 1) Ensure that products manufactured, tested, processed, stored and distributed are compliant with applicable regulations and quality systems 2) Establish quality systems, policies, objectives, initiatives and organizational structure that support the organization?s global quality reputation 3) Develop quality strategic plans, budgets and establish overall departmental goals 4) Create quality processes and strategies to ensure compliance with all regulatory agencies and improve internal quality practices 5) Lead the development of company?s quality culture to ensure employees are aligned with the company?s quality vision 6) Develop and lead staff and processes for all corporate quality system functions, including document control, change control, equipment validation, computer validation, look backs and deviations 7) Develop and implement a robust tracking and trending process that provides excellent information to the organization to improve overall quality processes 8) Develop and implement a robust process for customer notifications resulting from look backs and/or deviations as well as ensure that all notifications meet specified timelines 9) Develop and implement a robust process for company equipment and process validation requirements 10) Establish and lead the cross functional monthly quality review meetings to ensure effective communication and drive quality improvements throughout the organization 11) Provide leadership and guidance to the change control board 12) Ensure cross functional group manages process changes in a timely manner adhering to company policies and regulatory requirements 13) Represent corporate management during corporate QA regulatory audits and provide responsive leadership during the course of the audit 14) Oversee preparation, editing and revisions of Standard Operating Procedures and policies based on needed process improvements and/or changes in regulatory requirements 15) Develop quality system process improvement initiatives, including automation via master control 16) Develop reporting tools and metrics monitoring the performance of each quality system 17) Evaluate corporate QA staff performance and provide development direction to QA staff 18) Assume other responsibilities as directed by the Sr. Director, Regulatory Affairs and Quality Assurance
