Job Category: Quality Assurance and Testing
Job Number: 10892777
Akraya is looking for a QA Compliance Manager for one of our clients. If the job description below is a fit, please apply directly or call Chetna Kumari at 408-329-6544. If this position is not quite what you’ re looking for, visit akraya.Com and submit a copy of your resume. Our recruiters will get to work finding you a job that is a better match at one of our many clients.
Primary Skills: Pharmaceutical Industry experience, QA compliance regulations, Quality Agreement
Duration: 12 Months
Contract: Type: W2 only
- The Manager, QA Compliance will report to the Associate Director, QA Compliance – Global Quality Agreements within the Supplier Management and Audits department. This is a newly created position dedicated to support of the establishment, implementation and maintenance of the Global Quality Agreement Program initiatives.
- This position will have high visibility and will collaborate with essential key internal partners/stakeholders to ascertain Quality/business requirements to establish effective and timely Quality Agreements with various types of GMP suppliers/service providers, customers and strategic alliance/marketing partners.
- Responsible for assisting with the implementation of the Global Quality Agreement Program initiatives (governance, oversight, processes and services) by collaborating cross-functionally and geographically with key stakeholders
- Coordinate systems and procedures related to processing of QAGs; prepares/assembles the final QAG package for authorized approval signatures and publishing in global electronic QAG life-cycle management system / repository
- Creates training materials and conducts training related to QAGs, the Global QAG Program and its systems and tools
- Collaborates with key stakeholders to develop standardized, fit-for-purpose QAG Templates; Manages the review, approval, issuance, revision and retirement of QAG Templates
- Provides global QAG Program systems and processes support to SMA/QAG team and participates in system and process improvements and remediation (perform gap assessments and participate in development and execution of remediation strategies
Knowledge, Experience & Skills:
- Other duties as required or assigned by Manager to meet business needs
- Assigns, monitors and reviews progress and accuracy of work for an individual, a group of employees, or a project.
- Follows up on questions from assigned departments.
- Leads by example to foster a commitment to quality in personnel, and a culture of quality within the organization.
- Assists with maintaining standard of quality for compliance department operations.
- Assists in regulatory agency inspections.
- Interacts and influences peers to ensure successful project completion.
- Maintains current knowledge of Compliance program and of applicable company standard operating procedures for areas of responsibility.
- Provides guidance on interpretation and application of specified QA compliance regulations.
- Assists in the evaluation and implementation of standard operating procedures and systems needed to comply with requirements.
Specific Education Experience:
- Demonstrates excellent organization skills and ability to work on a number of projects to tight timelines.
- Demonstrates excellent attention to detail, and ability to consistently meet high standards of quality required in QA Compliance.
- Capable of taking a leadership role in updating and preparing the company for minor changes in regulations.
- 8+ years of relevant experience in the pharmaceutical industry and a BS or BA.
- 6+ years of relevant experience and a MS
- Demonstrates expertise with quality agreements for both domestic and international GMP regulations and/or extensive contracting (contract drafting/negotiating) experience in the pharmaceutical/biopharmaceutical industry
- Demonstrates the ability to incorporate sound Risk Management fundamentals in the establishment of quality agreement content
- Demonstrates excellent technical/business/legal writing skills; must have strong document or contract management skills (word processing/formatting)
- Excellent working knowledge of computer systems/applications; i.E. Microsoft Word, Excel, Pivot tables, Visio, Gantt Charts, and PowerPoint
- In-depth experience with electronic document control management or electronic contract life-cycle management systems (e.G.: Documentum, Veeva Quality Docs, Apttus, Ariba, or other electronic document control/contract life-cycle management systems)
Please apply directly with your update resume or call Chetna @ 408-329-6544
Akraya, Inc. Is an award-winning staffing firm that works with many of the leading, technology-based companies around the world. We have been ranked as one of the “ Best Staffing Firms to Temp for” by Staffing Industry Analysts on multiple occasions and are a preferred staffing vendor within numerous staffing programs. Please visit akraya.Com to search through all of our current openings or to submit your resume to our recruiting team.