GCS Inspection Readiness Lead

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.

You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight. Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on to ensure that the quality assurance programs and policies are maintained and modified regularly. You will make sure that there are uniform standards worldwide and best practice sharing, which will help in fostering the achievement of the company's mission globally.

ROLE SUMMARY

The GCS Inspection and Risk Management Group instills concepts of Risk Management and Inspection Readiness through Global Clinical Supply to ensure that clinical trial project work is conducted to internal and external standards and can withstand Regulatory Inspection. The position includes interaction with a diverse range of internal stakeholders, potentially including representatives from across the Global Product Development (GPD) organization and Medicinal Sciences. The GCS Inspection Readiness Lead is responsible for directing and managing Inspection and Audit Readiness activities for Global Clinical Supply (GCS). This includes close liaison with Clinical Supply Teams (CST) and PharmSci Quality Assurance colleagues to trigger and facilitate line discussions to ensure state of program inspection readiness at all times. Establishing and maintaining engagement with Global Regulatory Affairs Quality COE and Medical Quality Assurance (GCP quality) is critical. The role requires understanding of GCP and GMP to support the regulatory requirements and needs of different study types, quality management, inspection readiness, audit/inspection process, Clinical trial processes and systems within GCS. Strong organization and communication skills, both written and oral, are critical.

Inspection Readiness Management

• Proactively ensure that information relevant to inspection and audit readiness are initiated and maintained throughout the conduct of a protocol.
• Initiate inspection readiness tools such as GCS Inspection Readiness Storyboard and work with the CST to further refine.
• Act as the GCS point of contact with GRA Quality COE Inspection Readiness team, MQA Inspection Management team and PharmSci QA for audit and inspection preparation, response findings and required communications.
• Notify GCS program and functional line SMEs of upcoming audits and inspections.
• Share audit and inspection updates with GCS LT
• Coordinate and gather information during Inspections and audits, attend opening, closing, debrief meetings
• Lead meetings to address audit and inspection finding with identified SMEs Update GCS Inspection Readiness SharePoint Site with expected and announced audits and inspections, progress of completed work, etc.
• Participate in trend analysis and lessons learned and proactively share and manage components relating to GCS
• Use of Spotfire or similar visualization tools in audit and inspection preparations and evaluate areas for improvement
• Work in collaboration with GRA Quality COE Inspection Readiness team and MQA Inspection Management team for inspection preparation, response findings and required communications.
• Utilize and share learnings, perform lessons learnt from inspections to advance quality culture.

Quality Management

• Maintenance of GCS Inspection and Risk Management SharePoint site with quality and compliance resources, guidance, and tools
• Ensure compliance with applicable SOPs and Business processes spanning Medicinal Sciences and Global Product Development (GPD) as required. Review/evaluate and propose process or training enhancements
• Escalate concerns to Head of GCS Inspection and Risk Management and PharmSci QA related to timelines, engagement, and quality.
• Work across GCS functional lines and PharmSci QA to manage and deliver responsibilities
• Use of data applications to surface, highlight, manage and share information to improve quality across GCS in functional line meetings, lesson learned
• Support or lead technological enhancements
• Support or lead trending and monitoring in efforts to ensure that the conduct of clinical trials complies with stringent scientific and ethical standards.
• Attend GCS Quality Governance meetings as needed

• Bachelor's Degree
• 5+ years of pharmaceutical experience with solid experience in clinical studies, investigational supplies, supply chain, GMP/GCP Quality
• Demonstrated organizational and project management skills
• Demonstrated strength in analytical skills and attention to detail
• Good understanding of relevant regulatory and audit frameworks that apply to the biopharmaceutical operations
• Ability to manage multiple complex projects and has business acumen
• Excellent interpersonal effectiveness and written and verbal communication skills
• Technical proficiency, including skills in use of common desktop tools (MS Word, MS Excel, MS Project, Visio); Office365 and SharePoint; tools for analysis and graphing and reporting (Spotfire)

• Ability to progress work activities with oversight
• Regulatory inspection experience
• Knowledge of clinical trial processes and relationships
• Knowledge of GCP requirements and applicable SOPs and regulations
• Project management, administrative, and technical capabilities
• Strong and effective verbal and written communication skills
• Attention to detail
• Quality or compliance experience
• Scientific background in Life Sciences, Regulatory Affairs
• Strong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlines
• Ability to adapt to changing situations and work well under pressure

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

May include domestic and international travel to GCS sites

May periodically require working across US, EU, Asia hours to support regulatory activity and/or engagement with global colleagues

Other Job Details:
Work Location Assignment:Flexible

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.