Pfizer
SupplyOperationsQuality(SOQ)SeniorManager/ResponsiblePerson(RP)–Poland
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“Supply Operations Quality (SOQ) Senior Manager / Responsible Person (RP) – Poland at Pfizer. Skills: Supply Operations Quality, Responsible Person, Quality assurance, Compliance. Ensure effective processes and resources for meeting complaint. Ensure effective processes and resources for meeting notification”
What You'll Achieve.
Meet complaint handling timelines; Meet notification requirements; Enhance compliance; Enhance efficiency
Industry & Context.
Problem-solving skills; Develop solutions to complex problems
What They're Looking For.
Must Have
University degree in Pharmacy, Life Sciences, or related field, 10 years of experience in pharmaceutical quality, manufacturing, or distribution, Demonstrated expertise in people management, Proven track record of leading high-performing teams, Proficiency in word-processing, spreadsheet, and presentation software, Familiarity with role-specific tools like LabWare LIMS, Understanding of quality assurance and compliance processes, Ability to manage multiple projects, Ability to set objectives for direct reports
Nice to Have
Master’s degree with relevant pharmaceutical experience, Excellent understanding of local regulations surrounding GMP for finished pharmaceuticals, Good grasp of risk management methodologies, Proven ability to apply risk management to Bio-pharmaceutical operations, Ability to champion innovation, Ability to take appropriate risks, Experience in managing direct reports, Experience ensuring alignment with company standards, Experience using common AI tools, Experience with generative AI technologies, Demonstrated curiosity for exploring AI tools, Understanding of responsible AI practices
What You'll Do.
Ensure effective processes and resources for meeting complaint
Ensure effective processes and resources for meeting notification
Confirm compliance with Global SOPs
Complete gap analysis reports
Provide necessary training
Lead preparation for GMP inspections
Lead coordination for GMP inspections
Lead preparation for GCP inspections
Lead coordination for GCP inspections
Lead preparation for GDP inspections
Lead coordination for GDP inspections
Lead preparation for MAH inspections
Lead coordination for MAH inspections
Oversee quality of local contractors
Oversee quality of Logistic Service Providers
Oversee quality of re-labelers
Oversee quality of re-packers
Identify quality continuous improvement efforts
Implement quality continuous improvement efforts
Set objectives for direct reports
Ensure frequent review of direct report goals
Ensure all colleagues have Individual Development Plans
Provide technical leadership
Provide functional leadership
Manage direct reports
Ensure alignment with company compliance standards
Ensure alignment with company quality standards
How You'll Work.
Team & Collaboration
Cross-functional teams; Regulatory Authorities; Internal auditors
Communication Scope
Verbal communication; Written communication; Interpersonal communication
Process & Methodology
Manage multiple projects
Full Job Description
**Use Your Power for Purpose** Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative, flexible, and customer-oriented science and risk-based compliant quality culture drives everything we do. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution is vital and directly impacts patients. **What You Will Achieve** **In this role, you will:** * Ensure effective processes and resources for meeting complaint handling timelines and notification requirements * Confirm compliance with Global SOPs, complete gap analysis reports, and provide necessary training * Lead preparation and coordination for GMP, GCP, GDP, and MAH inspections by Regulatory Authorities or internal auditors * Oversee quality of local contractors, including Logistic Service Providers, re-labelers, re-packers, and other applicable contractors * Identify and implement quality continuous improvement efforts to enhance compliance and efficiency * Set objectives for direct reports aligned with global and local business goals, and ensure frequent review of these goals * Ensure all colleagues have Individual Development Plans that align with their development needs and the organization's vision * Provide technical and functional leadership, manage direct reports, and ensure alignment with company compliance and quality standards **Here Is What You Need** (Minimum Requirements) * University degree in Pharmacy, Life Sciences, or a related field, with a minimum of 10 years of experience in the pharmaceutical quality, manufacturing, or distirbution. * Demonstrated expertise in people management and a proven track record of leading high-performing teams * Exceptional leadership skills, along with strong verbal, written, and interpersonal communication abilities * Proficiency in word-processing, spreadsheet, and presentation software * Familiarity with role-specific tools like La
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