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Job Title: Associate Director QA Documentation Control
Date Posted: May 19, 2017
Reference Number: 3498_1974
Agency / Company Name: Pharmacyclics
City: Sunnyvale
County / State: CA
Country: United States
Postal Code: 94091
Description: General Position Summary:
Leadership role in ensuring establishment and maintenance of compliant, efficient Quality Assurance Document Management systems and procedures.
Key Accountabilities/Core Job Responsibilities:
  • Independently manages day - to-day Document Control activities. Manage team activities; Review and approve Document Change Request packages
  • Independently manage the administration of the electronic quality I document management system .
  • Evaluate potential impact of proposed changes to Electronic Quality Events and Document Management system
  • Define, develop, prepare and present document control metrics and reports.
  • Define and develop action plans to correct negative trends in document control metrics .
  • Independently initiate and approve SOP updates and creation of new SOPs. Additionally, oversees review of SOPs
and associated documentation to ensure biennial review requirements are met .
  • Ensures department readiness for regulatory i nspect i ons. Lead back room support team.
  • Ensures document control procedures and department records management processes comply with applicable regulations and guidelines.
  • If this position has direct reports :
    • Provide technical guidance and timely performance feedback through routine 1 : 1 meetings.
    • Provide technical development through OTJ training.
    • Work with HR to ensure opportunities for professional development.
    • Assist with developing individual goals and objectives .
  • If this position has group oversight responsibilities :
    • Establish the objectives of the group to *comply w i th the key objectives of the business
Education and Training: (degrees, certifications)
  • Minimum BA/BS degree preferably or equivalent professional experience
Experience:
  • Minimum 10- 1 2+ years of progressive pharmaceutical experience in a GMP environment executin g , developing, and administrating Quality I Document Control systems
  • 10+ years experience administering and managing electronic document management tools
Specific Skills/Abilities:
  • Excellent working knowledge of global GMP regulations, ICH guidelines and robust Quality Systems.
  • Broad experience in the pharmaceutical industry preferably with analytical and/or manufacturing background.
  • Detail oriented with demonstrated problem solving acumen.
  • Ability to work effectively in a team environment with great organization skills, and develop staff appropriately
  • Ability to independently analyze and reconcile complex issues.
  • Must be an individual with proven initiative and accountability
  • Must be able to lead in a fast-paced environment.
  • Excellent verbal and written communication and interpersonal skills.
  • Proficient with computers and typical office software (i.e., Microsoft Office products, EDMS, LMS).
Posses s an industry best practice perspective and demonstrated achievements
Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Salary:
Education:
Job Type:
Category: Quality
Experience:
Home Based or Virtual Position: No
 
   

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