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Senior Process Control Manager

Kelly Services


Location:
East Hanover, NJ
Date:
04/23/2018
2018-04-232018-05-22
Job Code:
US41L7BS_BH1432768
Categories:
  • Healthcare
  • Clinical Operations
  • Monitoring
Kelly Services
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Job Details

Job Title Senior Process Control Manager

Jobid US41L7BS_BH1432768

Location: East Hanover, NJ, 07936, USA

Description Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Sr. Process Control Manager** at a prestigious Fortune 500® company working in **East Hanover, NJ.**

**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the “Submit Resume” button included within.

**Job Title** : **Sr. Process Control Manager**

**Position Summary** :

Metrics and Quality KPI – Leads the tracking and reporting of compliance to the established clinical trial processes. Responsible to analyze, track, report and reinforce adherence to applicable performance measures. Oversees and recommends corrective actions based upon report outputs; ensures that training is developed and implemented as applicable to redirect teams to better Quality KPI scores. Tracks audit and inspection findings, report on results, track trends, generate lessons learned. Ensures effective ongoing operations of the Risk Mitigation Assessment process to improve the rate of compliance of countries to quality standards.

Process Expertise – serves as subject matter expert and input into new SOPs, ensures compliance to and adequate training opportunities for new SOPs and Business Guidance. Serves as Lead SME on the monitoring processes as requested. Tracks deviations from Monitoring SOPs and ensures appropriate documentation is filed and corrective actions are taken. Identifies procedural gaps and drives correction with process improvements where applicable. Conducts and supports conduct of vendor qualifications as needed; documents and files qualification evidence appropriately.

Process Compliance – Ensures CAPA commitments are adequate, submitted and completed in a timely manner. Ensures audits and inspections are supported, tracked and outcomes requiring corrective action are managed. Reviews CAPAs and makes appropriate recommendations to keep consistent. Initiates and documents root cause investigations of critical issues in collaboration with Quality Assurance and Clinical Operations. Supports the generation and dissemination of Tactical Memos and Lessons Learned communication in collaboration with monitoring training. Leads the conduct of Trial Master File quality control checks. Ensures compliance with required training by tracking and reporting compliance status for the Global, Regional and Country level organizations. Identifies gaps and assign action where needed to promptly gain compliance.

Inspection Readiness – Leads inspection preparation and execution as well as inspection readiness activities. Supports registration trial readiness by leading the planning and conduct of an annual self-assessment and facilitates spot checks in conjunction with that being done at the study level by the clinical team. Escalates issues to management and CQA in a timely manner. Ensures that actions required are appropriately taken. Ensures procedural deficiencies are corrected and prevented. Liaises with Regional Process Control Managers (rPCM) to ensure local quality is acceptable. Leads inspection response development and implementation as required by the business.

**Skills**

A minimum of 8 years in a R&D regulated environment in a relevant pharmaceutical or health care company, desirable clinical operations experience

Extensive knowledge and experience in ICH-GCP Process Control or ICH-GCP Quality Assurance systems and Health Authority regulations

Demonstrated ability for leading initiatives with cross-functional teams and implementation of recommendations

Experience working in matrix environment and in global teams

**Education**

College or university degree with significant life science experience. Advanced degree preferably in life sciences is preferred

Fluent in both written and spoken English

**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com at http://www.kellyservices.com/ **.**

**_Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**

**Kelly Services is an Equal Opportunity Employer**

**Why Kelly** **®** **?**


With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



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