Senior Manager, GMP Auditor

ROLE SUMMARY

Science is the foundation of all that we do at Pfizer. We are seeking a Senior Manager, GMP Auditor who 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.

TheSenior Manager, GMP 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 RESPONSIBILITIES

• Independently 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 assessments
• Acts as a reviewer of audit reports from outsourced or routine audits
• Assesses audit plans and quality metrics to identify potential areas of risk
• Actively supports regulatory inspections as needed
• Identifies and drives process improvements
• Delivers awareness sessions with oversight by manager on various GMP topics internally and externally
• Drives 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 QA
• Actively engages in discussions to determine impact of changing needs of the regulatory environment
• Works with RQA colleagues on cross GxP audit plans as required
• Coaches colleagues and leads training for routine and non-routine site and process audits
• Advises business representatives (e.g. BPOs) on outcomes of complex audits and provides input to process improvement activities
• Independently/with minimal supervision demonstrates leadership by providing clients with influence and recommendations to meet changing GMP business needs

BASIC QUALIFICATIONS

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including the ability to influence and collaborate with peers, develop and coach others, and oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

• BS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent
• Demonstrates 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 operations
• Displays critical thinking expertise, with ability to define and implement a strategic approach to audit based on compliance and business knowledge
• Strong use of quality and auditing frameworks and application
• Routinely suggests new audit techniques and approaches, and operationalizes to improve the audit system
• Ability to identify trends within data and apply insights to make recommendations and decisions
• Ability to bring recommendations to stakeholders for discussion and input
• Actively leads and progresses efforts to deliver operational improvements
• Exhibits good project management capabilities
• Has domain expertise in 2 or more technical areas
• Ability to work with ambiguity and adapt plan when needed
• Experience evaluating and understanding quality standards or their application
• Uses and interprets qualitative/quantitative data to drive decision making,
• operationalize recommendations and understand potential impact to other areas of the business
• Acts as a specialist in complex technologies (e.g., sterile injectables, low bioburden, biotech, MDCP); can perform special assessments and participate on process audit teams

PREFERRED QUALIFICATIONS

• Has 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 and acquires feedback on audit outcome
• Preferred experience in audits with a background in GMP, Process or other related quality areas
• Expertise in 1+ major areas (MDCP, aseptic manufacturing, etc.); and 2+ minor specializations OR 2+ major and 1+ minor
• Ability to function autonomously in a matrix model and in a team environment
• Provides training/mentorship to other auditors or SMEs

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• The travel requirement may be approximately40%

Other Job Details:

• Last Date to Apply for Job: February 22, 2021
• Additional Location Information: New Jersey - Remote; North America - Any Pfizer Site; North America - Remote; Manhattan, NY; Collegeville, PA; United States - Remote
• Eligible for Employee Referral Bonus

Sunshine Act

Pfizer 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.

EEO & Employment Eligibility

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.

Quality Assurance and Control

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