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: Manufacturing Quality Analytical Manager
Pay: $66.02 per hour
o Management of analytical tech transfer activities across API & Drug Product in an external manufacturing environment
o Provision of analytical expertise and troubleshooting support in the areas of API’s and intermediates, drug products, raw materials, and Pharmacopoeia requirements in an external manufacturing environment
o Proactively manage all API & Drug Product Contract Laboratory Service (CLS) providers to Global External Manufacturing from a quality and compliance oversight perspective.
o Engage with internal and external stakeholders to plan and manage the program for analytical method transfers from Company to CMOs or CMO to CMO.
o Represent Global External Manufacturing as the QC laboratory subject matter expert in support of due diligence audits and for cause audits where laboratory related issues are a focus for such audits
o Review and approve all major laboratory investigations/OOS events at CMOs & CLS providers.
o Provide technical support to the QP and Quality Operations Managers in relation to same.
o Review and approve analytical change control documents associated with CMOs & CLS providers
o Facilitate and manage the communication flow to and from CMO analytical functions and global functions across Global Testing Standards, HQ
o Reference Standards Management Team, Global Analytical Services, Global Regulatory Sciences etc.
o Review and approve analytical method validation documentation & activities at CMOs and CLS providers to determine compliance with ICH requirements and manage remediation of gap analysis at the company or CLS
o Provide analytical expert support for regulatory submissions
o Prepare, approve and maintain the Quality Agreement with each CLS provider.
o Establish and monitor an effective metrics program to measure the performance of the CLS providers.
o Provide training to wider External Manufacturing team
o Ability to work independently and within team matrix environments
o Thorough knowledge of worldwide regulatory GMP requirements and a working knowledge of FDA & EU GMP requirements
o In depth knowledge of Quality Management Systems relating to laboratory operations
o Ability to objectively critique investigation reports from third parties
o Good knowledge of API and Drug Product processes and ability to differentiate between requirements
Required Qualifications and Desired Experience
o In depth knowledge and operational experience at management level in a Pharmaceutical QC laboratory
o API and Drug Product experience
o Strong knowledge of analytical technical transfer processes, compliance requirements and proven troubleshooting skills
o Project Management skills are required
o Strong technical knowledge of modern chromatographic methodologies.
o Management of Third Party relationships (desirable)
o A minimum of 5 years experience in a QC/QA environment is required for this role.
o A minimum of a BSc in Chemistry or related discipline is also required together with a sound understanding of GMP & ICH guidelines.
We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: 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
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 interests-it's 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.
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're 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. 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.]]