GenAI Operations Manager
Caterpillar Inc.
Manager, External Quality Operations
Pfizer
full-time
Posted on:
Location Type: Office
Location: Illinois, New York, North Carolina, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $96,300 - $160,500 per year
Job Level
Mid-LevelSenior
Tech Stack
Vault
About the role
- Manage all aspects related to product quality or compliance for a portfolio of external contract manufacturers and suppliers
- Assess the quality of external supplier’s products, processes and related documents while ensuring the product specifications are met
- Support internal and external partners with auditing activities related to ESOQ activities
- Support internal and external partners with Compliance Assessments to ensure current GMP/GDP adherence
- Manage Risk at Vendors implementing Quality Improvement Plans
- Support onboarding activities of new CMO’s or product launches
- Make product Quality decisions leveraging comprehensive knowledge of Quality/Manufacturing principles
- Influence quality decision making in line with industry and Pfizer requirements
- Provide Quality Leadership within the cross functional virtual site operating teams (VSOT)
- Partner with colleagues to develop and negotiate quality agreements
- Review and approve Annual Product Review and Product Quality Review (APR/PQR) reports
- Perform batch disposition endorsement
- Identify, develop and implement continuous improvement initiatives related to ESOQ processes
- Ensure the adequate tracking and documentation of all required quality related actions
- Lead and support complex investigations, market complaints, risk assessments in support of products within your portfolio
- Support Global Logistics and Network Services team to ensure GDP oversight is maintained during manufacture and shipping of medicinal product
- Provide Performance Metrics for key performance indicators
Requirements
- Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR an associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience
- Experience with external suppliers/contractors
- Advanced computer skills for MSOffice and enterprise systems such SAP, QTS, Vault, Documentum platforms, Minitab
- Proficient in English and technical writing
- Strong verbal, written communication, and presentation skills
- Demonstrated personal leadership to work in virtual teams and cross functional projects/initiatives
- Demonstrated experience managing complex quality and compliance activities
- Problem solving attitude and open to innovation
- Demonstrated managerial/organizational skills
- Takes initiatives and is proactive, persistent
- Good organizing and planning skills and a high sense of urgency
- Demonstrated ability to act and work independently and to report items as required to line manager
- Demonstrated knowledge of US, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices
- Demonstrated technical know how
- Proven leadership/facilitation skills and being able to involve several levels of an organization to successfully meet the objectives
- Demonstrated experience in pharmaceutical manufacturing activities (API, DP, Biotech, Oral Solid Dosage, Aseptic) applicable to the role
- Experience on managing investigations (DMAIC, 6sigma, ...)
- Demonstrates the ability to influence and collaborate with peers
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Pfizer Retirement Savings Contribution
- Paid vacation
- Paid holidays
- Paid personal days
- Paid caregiver/parental leave
- Paid medical leave
- Health benefits to include medical coverage
- Prescription drug coverage
- Dental coverage
- Vision coverage
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality managementcompliance assessmentsrisk managementcontinuous improvementtechnical writingpharmaceutical manufacturinginvestigationsGMPGDPdata analysis
Soft skills
communication skillsleadershipproblem solvingorganizational skillsinitiativeplanning skillscollaborationinfluencepresentation skillsindependence
