QO Manager ComplianceTL

Use Your Power for Purpose

Candidate will be responsible to provide leadership for will be responsible for managing a team of Compliance QA Documentation Supplier Management Validation Sterility Assurance Combination Product Quality and Data Integrity within the Rochester Quality organization.

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 sites monthly Site Quality Review Team/Management Review meeting. Manage and lead for sites 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.

What You Will Achieve

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 agencys guidances 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 noncompliance. 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 agencys guidances 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 Inprocess 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 for remediation of gaps and maintaining compliance between the onmarket 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 sites 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)

Here Is What You Need (Minimum Requirements)

• Education: Applicant must have a bachelors degree with at least 4 years of experience; OR a masters degree with at least 2 years of experience; OR a PhD with 0 years of experience; OR as associates degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant 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 inprocess materials and final product.

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 2530 lbs.

NONSTANDARD 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.

Work Location Assignment:On Premise

The annual base salary for this position ranges from $102900.00 to $171500.00. In addition this position is eligible for participation in Pfizers 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 lifes 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 . 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.

Quality Assurance and Control

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