Provides guidance and coaching to QO colleagues and provides direction/approval of activities and decisions. Cultivates and reinforces appropriate group values, norms, and behaviors. Provides oversight to individuals and team on personal development, performance, and quality related issues. Writes and delivers performance reviews and performs second level reviews as required. Provides oversight of department, ensuring proper use of assets, budget, and personnel. Communicates effectively with key customers and partners, both within the site and outside of it.

This role will require cross departmental and company interactions as well as participates in internal, corporate, and agency audits/inspections. Monitors and reports quality metrics for the site's monthly Site Quality Review Team/Management Review meeting. Manage and lead for site's QIP (Quality Improvement Plan) and IR (Inspection Readiness) Program.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

This position leads a team of individual contributor direct reports with a wide range of quality responsibilities including; Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, Combination Product Quality, and Data Integrity.

Compliance, QA Documentation, Supplier Management: Candidate will ensure that site standards, policies and procedures are aligned with global Pfizer Quality Standards, regulatory agency's guidance's and are operating in a state of compliance. Ensure that Rochester remains in an inspection readiness state by conducting internal site systems audits, monitoring and generating compliance/quality performance indicator metrics, performing gap assessments and addressing any areas of non-compliance. Coordinates supplier management program, Medical Device & Combination Products (MDCP) activities, investigates product complaints, and generates annual product reviews. Manages QA Documentation department involving processes for SOPs, master batch records, specifications, test methods, OJTs, validation protocols/reports, technical protocols, reports, and other GMP documents.

• PQS (Pfizer Quality Standards)
• Site Inspection Readiness Program
• FARs and AQRT Programs
• Site Internal Audit Program
• Balanced Score Card and MDCP Metrics
• Site Quality / Management Review Team Meetings
• Supplier Management Program
• QA Documentation Control Program
• Support regulatory agency/corporate inspections
• Point of contact for regulatory inquiries

Validation and Sterility Assurance: Candidate will be responsible for ensuring that the sites Validation and Sterility Assurance standards, policies and procedures are aligned with global Pfizer Quality Standards and regulatory agency's guidance's and are operating in a state of control. Responsible for providing oversight of the following programs: change control, validation, quality risk management, aseptic and microbiology support (processing, technique/clean room behaviors, environmental/critical utilities/personnel monitoring, facility cleaning and sanitization, sterilization, media simulation, microbial tracking/trending), and Medical Device & Combination Products (MDCP).

• Validation Master Plan
• Change Control Program
• Quality Risk Management program
• Sterility Assurance Assessments for investigations and changes controls
• Media Simulation Program
• Maintain the sites air flow visualization program
• Maintain the sterilization qualification/requalification program
• Maintain the facility disinfectant and sanitization qualification program
• Provide oversight of the Environmental and Personnel Monitoring Program
• Provide assistance/oversight for the resolution regarding events that impact the aseptic quality to assure event is contained and appropriate steps are taken to mitigate risk to product and the environment
• Provide assistance/oversight with coordinating activities to return manufacturing areas to aseptic conditions following plant shutdowns or break in asepsis
• Provide assistance with general microbial testing/qualification activities (Raw material, In-process, Product and Shelf-Life product testing and critical utilities monitoring)
• Compile and/or assess monthly and quarterly tracking/trending reports to ensure compliance with cGMP s and facility construction/maintenance requirements.

Combination Product Quality/Data Integrity: Candidate will be responsible to ensure systems are in place to assess impact to combination products and Data Integrity. Responsible for remediation of gaps and maintaining compliance between the on-market product and the Design History File (DHF) and Data Integrity as required. Provide oversight and guidance for risk management file lifecycle activities for combination products. Leads and facilitates risk assessment activities and guides design verification and validation plans.

• Evaluates changes that impact combination products, including change controls, complaints, sop revisions, and investigations associated with Post market surveillance
• Leads the evaluation of adequacy and compliance of the site Quality Management System against all applicable medical device/combination product regulations and company policies and procedures
• Evaluate supplier changes that impact combination products
• Provide site technical guidance for combination product device changes, document updates, process changes, device risk management
• Owner for risk management file documents/records
• Leads the planning and implementation of Risk Management efforts, including establishing and revising system and procedures governing risk management
• Review and establish link to the risk file for complex/significant CAPA, investigation and Change Management records
• Facilitate risk assessment activities, risk mitigation strategies and risk management plans; provide review/approval as needed
• Support day to day support for design changes, complaints, procedures, investigation, CAPA, management review
• Lead the site's Data Integrity Quality System, including development and leadership of appropriate governance, development and institution of requisite policies and procedures, establishment of sustainable and effective means of quality performance monitoring
• Data Integrity Program
• Medical Device and Combination product program - conduct regulatory assessments, create/maintain design history file, participate and develop MDCP FMEAs, develop and report on key performance indicators (metrics), conduct internal audits, impact assess design changes.
• CAPA Review Board (CRB)

Qualifications

Must-Have

Education: Applicant must have 10 years of relevant experience; OR an Associate's degree with eight years of experience; OR a Bachelor's degree with at least five years of experience; OR a Master's degree with more than three years of experience; OR a Ph.D. with 0-2 years of experience.

• Experience in a cGMP environment, with a strong working knowledge of a variety of quality systems, aseptic manufacturing and processes including Drug and Combination products.
• The candidate must have demonstrated proficiency in organizational skills, balance multiple priorities, aptitude for technical learning, and problem solving
• Understand regulatory requirements and audit strategy
• Basic understanding of aseptic manufacturing
• Knowledge of drug/device combination product requirements is highly desirable
• Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies.
• Knowledgeable in aseptic process/techniques, media simulations, air flow visualization, environmental monitoring, personnel monitoring, critical utility monitoring, sterilization processes, deviation investigation, and equipment/method validation.
• Ability to thoroughly evaluate quality investigations, deviations, laboratory investigations, and follow up actions are documented as they relate to the manufacturing, testing, distribution of raw materials, containers, closures, packing materials, labeling, in-process materials, and final product.

Nice-to-Have

• Knowledge of device/combination product industry regulations

PHYSICAL/MENTAL REQUIREMENTS

• This is a penicillin manufacturing facility. All candidates applying mist NOT be allergic to penicillin.
• Must be able to aseptically gown.
• Able to lift 25-30 lbs.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Non- Standard work schedule at times maybe required to support product release, including weekend, second shift, night shift work / call for process decisions.
• Minimal travel for training/seminars.

Relocation support available

Work Location Assignment: On Premise

Last Day To Apply: December 18th, 2024

The annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

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. This position requires permanent work authorization in the United States.

Quality Assurance and Control

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