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IT Regulatory Quality Manager (Pharma)- Remote!
What will I be doing?
The IT Regulatory and Quality Manager leads compliance initiatives in support of company policies, GxP requirements, for the Dialog Solutions business unit, which recently became ISO 9001:2015 certified. This exciting opportunity will have two direct responsibilities;Complete ownership of the Quality Management System (including the Learning Management System) as well as oversight of Validation activities to support the Drug Safety Triager.
In this position, you will also…
•Support Quality oversight and initiatives by further enhancing the Quality Management Systems through continuous improvement activities
•Draft, implement and improve upon Standard Operating Procedures, CAPAs, Change Requests and other Quality documentation
•Conduct training with various teams on GxP, GAMP and GVP requirements
•Create and conduct investigations for CAPAs, complaints and determine actual root cause analysis through use of 5 Why, Fishbone or the like
•Create and execute the annual Quality Plan to support business goals
•Support the already achieved ISO 9001:2015 certification by ensuring all requirements in standard are addressed
•Work with customers to understand and translate their GxP requirements to various internal departments such as Engineering.
•Enhance oversight and governance of the Quality Management System by further defining key Metrics and KPIs
•Facilitation of Internal, External and Regulatory audits as well as remaining the PoC/owner for audit observation mitigation
•Continue to foster and improve the Quality of Culture within the business
•Work with internal teams to ensure Validation expectations/requirements are part of service delivery and are met before product release.
•Further enhance Validation efforts by refining standard documentation included in Validation packages as per GAMP guidelines and customer requirements
•Provide oversight and ownership of the creation, collection, execution, approval and archiving of all Validation SDLC documentation
•Ensures IT systems and processes remain compliant with company policy as well as local, federal, and business rules and regulations.
•Maintains current knowledge of regulatory trends and communicates changing requirements to upper management.
Reasons you should apply...
1. You have experience with pharmaceutical regulation and compliance
2. You enjoy being an influencer and have leadership abilities
3. You enjoy initiating dialogue and conversations with our customers, making connections, and opening doors
This job may not be a fit if...
1. You prefer to identify a problem, but not be involved in figuring out how to fix it.
2. You don’t thrive in a dynamic environment and shifting priorities.
3. You shy away from having hard conversations and standing up to others when needed.
Qualified Candidates must have…
•Bachelor’s degree in related field such as Quality, Engineering, Business, plus 7 years of related experience in IT Auditing, Total Quality Management, GxP compliance, project management, or an equivalent combination of education and experience.
•Direct and/or indirect people management, either via direct reporting or matrix reporting relationship.
•Comprehensive understanding and demonstrated implementation of the following guidelines, standards and regulations:
•21 CFR part 11,210,211 and 820
•EudraLex Volume 4 Annex 11 –Computerised Systems
•EMA GVP
•ISO 9001:2015
•ICH Q9 and Q10
•GAMP 5
•Comprehensive understanding of Technology including
•Amazon Web Services
•Agile vs Waterfall Methodology
•Working knowledge of:
•Veeva QualityDocs
•UL Compliance Wire
•ASQ Certification or Equivalent.
•Self-motivated and able to work efficiently/effectively with minimal oversight
•Excellent verbal and written communication skills.
•Strong organizational skills with consistent attention to detail and ability to manage multiple priorities based on criticality.
Superstar Candidates will ALSO have…
•Experience in a similar or related industry and/or professional services environment.
•Experience in a role where you are more of a business consultant
More to love about becoming a PQ employee!
•This is a remote position
•Forbes Ranks ProQuest among 2018 America’s Best Mid-Size Employers
•We offer professional development opportunities with a significant focus on learning
•Our employee population is smart and highly collaborative
•All of our employees have access to ProQuest research products including e-books, genealogy and academic journals
At ProQuest, we work hard and have fun doing it. If you are someone who enjoys consulting the business and being part of an amazing product, please consider joining our talented team!!
EOE/M/F/Vet/Disabled