QO Manager Compliance/TL

QO Manager Compliance/TL

Requirements

• Education: Applicant must have a bachelor’s degree with at least 4 years of experience; OR a master’s degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR an associate’s 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, in-process materials, and final product.

Responsibilities

• Provide leadership 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.
• 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.
• 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.
• 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, and Medical Device & Combination Products (MDCP).
• Leads and facilitates risk assessment activities and guides design verification and validation plans.

Preferred Qualifications

• Knowledge of drug/device combination product requirements is highly desirable.