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14 days old

Director of Quality R&D

Kelly Services
Greenfield, IN 46140
**Director of Quality R&D**


Kelly Science & Clinical is looking for a REMOTE Director of Quality for our partner in the Pharmaceutical industry. This opportunity is working from home with possible travel up to 15% as needed.


**Position Description:** As a member of the globally integrated R&D Quality Assurance Leadership Team, this position **Director Quality R&D** is accountable for the oversight, direction, and management of the Quality R&D Americas Region organization to ensure the regulated activities of Regulatory are consistently and appropriately handled within Americas Region. This role provides compliance oversight and business partnership to R&D and Regulatory leadership to ensure that appropriate quality systems, procedures and resources are in place for effective execution of the R&D quality management system.


**Functions, Duties, Tasks:**


+ Responsible for the implementation of the global Quality Assurance and Compliance Strategy for Quality R&D and Innovation Regulatory including but not limited to external regulations, Global Quality Standards, and procedures.

+ Responsible for ensuring Quality oversight of R&D and Innovation Regulatory for Americas Region organization together with qualified staff, efficient processes, governance and in partnership with R&D and Regulatory leaders and staff.

+ Additionally, provision of guidance, support, and resources for globally integrated Quality R&D team.

+ Ensures that trained and qualified Quality resources are available to support the business needs, including, but not limited to, Clinical Efficacy GCP , Safety GLP , CMC GMP and associated Regulatory Authority Inspections.

+ Ensure robust development plans for ERDQA Americas Region talent to sustain local and global compliance and current state of industry and health authority positioning. This includes identifying individuals with leadership potential, providing mentoring and enrichment opportunities consistent with succession planning.

+ Provide leadership to ensuring clear definition, execution and understanding of roles and responsibilities. Head of Quality Assurance Unit for Fort Dodge R&D FDA GLP Test Facility.

+ Provide quality review of R&D Quality Management System e.g., standards and procedures and regulatory submission documentation. In partnership with R&D Leadership, drive quality culture within ERDQA Americas Region and global R&D and Innovation Regulatory.

+ Identify and drive continuous quality process improvements as a consequence of audits, assessments, inspections, trends, metrics, and root cause analysis Drive implementation of Quality by Design principles Actively participate and make meaningful contributions Deliver independent expert support and propose solutions Provide input to the EGQCA audit plan based on utilization, identified signals/trends/risks.


**Education:**


+ Master s Degree in Biology, Chemistry, Pharmacy, Science, Engineering, or related field

+ Bachelor s degree in Biology, Chemistry with relevant years of experience


**Experience:**


+ Demonstrated pharmaceutical drug and vaccine development experience, within an animal health and/or human health environment.

+ Demonstrated expertise in GLP and GCP regulations in one or more global regulatory environments (e.g., EMA, EPA, FDA, USDA). GMP knowledge a plus.

+ Demonstrated leadership experience operating within in matrix environment, including experience leading multi-cultural teams and influencing senior business partners and key stakeholders.

+ Effective interpersonal and communication skills; must understand how to influence and diplomatically challenge when needed.

+ Demonstrated ability to initiate and drive change within and across business functions, projects & the wider organization.

+ Proven track record with inspection management (e.g., FDA, EPA, USDA).


\#P1


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-07-29 Expires: 2022-08-29

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Director of Quality R&D

Kelly Services
Greenfield, IN 46140

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