Senior Manager, Auditor (US)

Company: Pfizer Belgium
Location: Sacramento
Posted on: May 25, 2023

Job Description:

Why Patients Need YouEverything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.What You Will AchieveScience is the foundation of all that we do at Pfizer. We are seeking aSenior Manager, Auditorwho will join a diverse team of dedicated professionals driven to significantly improve the lives of patients through his/her/their work at a company whose culture is committed to developing and nurturing diverse talent so that each colleague has the opportunity to build a fulfilling career.Regulatory Quality Assurance (RQA) is an independent Quality audit function within the Compliance division, accountable to identify risks and non-compliance associated with Pfizer's GxP regulated operations.This is an onsite position that will be located in San Jose or Emeryville, CA.How You Will Achieve ItThe GMP Senior Manager, Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GMP portfolio/programs/entities. This role is responsible for GMP Oversight and for assuring the compliance of projects, products and programs with Pfizer Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations, guidelines and standards (e.g., US FDA, EU Directives, National regulations, ICH, ISO)..ROLE RESPONSIBILITIESIndependently plans/leads/conducts wide range of (non-routine) complex audits including commercial/clinical manufacturing sites and contract manufacturers, and performs complex process audits with oversight.Executes audit strategy, leads process audits and performs special assessmentsActs as a reviewer of audit reports from outsourced or routine auditsAssesses audit plans and quality metrics to identify potential areas of riskActively supports regulatory inspections as neededIdentifies and drives process improvementsDelivers awareness sessions with oversight by manager on various GMP topics internally and externallyDrives interactions with QA colleagues at other Pfizer locations and organizations/functional lines to ensure consistency in application of QA strategy and to promote standardization of auditing approach within QAActively engages in discussions to determine impact of changing needs of the regulatory environmentWorks with RQA colleagues on cross GxP audit plans as requiredCoaches colleagues - leads training for routine and non-routine site and process auditsAdvises business representatives (e.g. BPOs) on outcomes of complex audits and provides input to process improvement activitiesIndependently/with minimal supervision demonstrates leadership by providing clients with influence and recommendations to meet changing GMP business needsBASIC QUALIFICATIONSBS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalentDemonstrates advanced knowledge in ICH and global regulations (e.g., FDA, EMA, HC, ANVISA, TGA) and international standards (e.g., ISO, WHO)Demonstrates comprehensive working knowledge of business concepts and quality operationsDisplays critical thinking expertise, with ability to define and implement a strategic approach to audit based on compliance and business knowledgeStrong use of quality and auditing frameworks and applicationRoutinely suggests new audit techniques and approaches, and operationalizes to improve the audit systemAbility to identify trends within data and apply insights to make recommendations and decisionsAbility to bring recommendations to stakeholders for discussion and inputActively leads and progresses efforts to deliver operational improvementsExhibits good project management capabilitiesHas domain expertise in 2 or more technical areasAbility to work with ambiguity and adapt plan when neededExperience evaluating and understanding quality standards or their applicationUses and interprets qualitative/quantitative data to drive decision making, operationalize recommendations and understand potential impact to other areas of the businessActs as a specialist in complex technologies (e.g., sterile injectables, low bioburden, biotech, MDCP); Can perform special assessments and participate on process audit teamsPREFERRED QUALIFICATIONSHas 8+ years of experience (2 levels; operations and auditing required)Lead audit teams (2-6 ppl per team)Demonstrates stakeholder and conflict management (communications, relationship management)Negotiates needs & acquires feedback on audit outcomePreferred experience in audits with a background in GMP, Process or other related quality areasExpertise in 1+ major areas (MDCP, aseptic manufacturing, etc.); and 2+ minor specializations OR 2+ major and 1+ minorAbility to function autonomously in a matrix model and in a team environmentProvides training/mentorship to other auditors or SMEsOther Job Details:Last Date to Apply: May 24, 2023Relocation assistance eligible: YesEmployee referral eligible: YesThe annual base salary for this position ranges from $113,900.00 to $189,700.00. In addition, this position offers an annual bonus with a target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans. Salary range does not apply to the Tampa, FL location.Relocation assistance may be available based on business needs and/or eligibility.Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Keywords: Pfizer Belgium, Sacramento , Senior Manager, Auditor (US), Accounting, Auditing , Sacramento, California