Job Description

Why Patients Need You

Everything 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 Achieve

You will be a member of Pfizers dedicated and highly effective quality assurance team. You will oversee the Quality Assurance Team responsible for drug substance testing support and be involved in drug product and/or site support as well as necessary. You will ensure the Quality Control labs are in compliance and have the support they require from a QA perspective. Your expertise will help in identifying deviations from established standards, and investigation support. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your will guide projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.

How You Will Achieve It

* Manage multiple projects and ongoing work activities within the division typically involving cross-functional representatives.
* Manage the specific Inspection preparation plan for key Good Manufacturing Practices (GMP) elements etc.
* Provides guidance and coaching to Quality Operations colleagues and provide direction or approval of activities and decisions.
* Provide Quality Assurance expertise to site and external parties as required.
* Identify continuous improvement opportunities based on metrics and drive consistency through the process to align with Pfizer's standard processes and quality systems.
* Manage site prioritization and management escalation meetings regarding AQRTs (Area Quality Review Teams).
* Assist in key site quality behavior establishment, set clear company policies and behavior expectation for team member.
* Prepare departmental budgets and control the departmental cost within the budgets.
* Interface with Regulatory Agencies in audits, track and report metrics for all internal auditing activities.
* Manage and monitor the audit report distribution process to ensure timely delivery of critical information to key stakeholders and complete regulatory commitments
* Assist Quality Control investigations for all planned and unplanned deviations, review and approval of product and lab equipment change controls.
* Take independent actions and decisions and motivate key stakeholders to deliver quality outcomes for business requirements.

Qualifications

Must-Have

* Bachelor's Degree in Chemistry, Engineering, Biology, Manufacturing Management, or related scientific discipline required.
* 10+ years of experience in pharma/biopharma industry required.
* 3+ years of direct management experience required.

Nice-to-Have

* Experience in QA and/or Manufacturing and/QC, experience dealing with Regulatory compliance.
* Experience in problem solving, process improvement, negotiations and supervision.

Physical/Mental Requirements

Normal lifting, sitting, standing and walking requirements to facilitate support of staff in the office and on the floor (laboratory, suites, etc.).

Non-Standard Work Schedule, Travel or Environment Requirements

This position is primarily Monday - Friday on day shift. 24/7 support of manufacturing as quality issues arise. Some travel may be required but expected to be minimal.

Other Job Details:

* Eligible for Relocation Package
* Eligible for Employee Referral Bonus
* LI-PFE

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 providers 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

LI-PFE