Quality And Compliance Lead

Why Patients Need You
The Drug Product Supply Global Materials Management team plays a pivotal role in assuring our breakthroughs make it to the hands of patients. At Pfizer, our Global Materials Management group (GMM) is responsible for all demand planning, sourcing, and material handling for products supporting the Pfizer clinical supply chain and portfolio. By leading and supporting the quality and compliance aspects of GMM, you will be driving best-in-class compliance practices, making our work compliant, more efficient, and allowing GMM to better supply our patients and continuously achieve breakthroughs that change patients' lives. What You Will Achieve
Pfizer's Pharmaceutical Sciences Drug Product Supply group is seeking a highly skilled, detail-oriented, and forward-thinking Quality and Compliance Lead with a focus on GMP principals across our Global Materials Management group. The successful candidate will ensure the highest level of quality and compliance across all aspects of GMM, collaborating with GMM leadership. The chosen candidate will be responsible for implementing and maintaining quality management systems and policies in accordance with regulatory requirements, Pfizer standards and industry best practices. The Quality and Compliance Lead will also play a key role in driving technology and innovation initiatives to enhance efficiency and effectiveness across the quality and compliance functions.
In this dynamic position, you will spearhead a comprehensive compliance strategy, ensuring alignment with regulatory and Pfizer standards, fostering a culture of excellence, and harmonizing practices for GMM across diverse and geographically dispersed facilities.
The successful candidate will be responsible for driving compliance related innovation while leading improvement teams/projects, ensuring effective implementations and operational compliance. The candidate will manage global/local trainings and SOPs, including trending and KPI's of compliance data.
The candidate will work closely with all GMM team members and collaboratively with a vast number of partner lines to support all facets of GMM operations/facilities. Remit will span across both small and large molecule. How you Will Achieve It Regulatory Compliance Interpret and stay updated on relevant regulation and guidelines from health authorities.
Represent GMM at the Pharm Sci monthly compliance meeting.
Become Subject Matter Expert (SME) and stay updated on relevant Pfizer Quality Standards (PQS).
Lead and support investigations related to materials, facilities, non-conformance, and supplier quality issues.
Ensure that all processes, documentation, facilities, and products comply with requirements.
Support regulatory and internal inspections/audits, collaborating with GMM leaders in addressing any findings and implementing corrective and preventive actions (CAPAs).
Build and execute a self-inspection program to drive and monitor GMP compliance and identify potential areas for improvement.
Lead GMM compliance forum and appropriate PQS teams.
Participate in highly matrixed cross-functional teams with operational leaders to prioritize strategic processes and roadmaps and drive innovation.
Oversight and support of partner groups working within GMM facilities (i.e. GCS, DPM, GWE).
Support GMM controlled substance program (DEA & CT Drug Control).
GMP (Good Manufacturing Practices) Compliance Set the strategic direction for quality and compliance throughout GMM.
Assure adherence to established GMP practices with a forward-looking perspective to anticipate and address emerging challenges across the business.
Assure comprehensive framework of practices, procedures and documentation requirements are in place and being always adhered to across the GMM.
Ensure a proactive and adaptive approach to evolving business landscapes. Champion the implementation of efficient and compliant processes.
Establish and maintain a seamless connection between materials management processes and overall quality initiatives through fostering a culture of quality and continuous improvement.
Lead and review quality/compliance documentation and implement processes to improve speed while focusing on quality, compliance and Right-First-Time (RFT).
Use a quality embedded mindset and practical knowledge of industry, customer requirements, and general business environment to define appropriate actions.
Leadership Provide strategic direction in interpreting and implementing evolving regulatory standards.
Develop and articulate a clear vision for compliance that aligns with overall business objectives.
Member of the Global Materials Management leadership team, actively contributing to the strategic direction and ensuring adherence to regulatory requirements across all facets of the group.
Demonstrate leadership qualities, serving as a mentor for junior colleagues and fostering a collaborative and growth-oriented environment within the team.
Prepare and present data on quality metrics, compliance status, and improvement initiatives.
Participate on GMM and DPS wide initiatives and limited duration teams.
Innovation Collaborate with cross-functional teams to develop and implement innovative solutions to improve business processes, reduce compliance risk, whilst driving efficiency.
Stay current on emerging technologies and trends to identify transformational opportunities.
Collaborate closely with the GMM strategy and project team to ensure harmonious integration of compliance and innovation, fostering cohesive partnerships to advance initiatives.
Risk Management Manage GMMs quality and compliance systems, leveraging data to analyze trends and KPIs.
Operate within quality management systems to lead, own, and drive investigations, corrective/preventive actions, change control and validation activities.
Training and SOP Management: Develop and implement training programs to enhance employee skills and process knowledge. Measure training effectiveness and make necessary improvements. Assure GMM remains informed about the latest GMP requirements and trends.
Author, review, maintain and update Standard Operating Procedures (SOPs).
Operational Excellence and Continuous Improvement: Establish feedback mechanisms to gather input from stakeholders and incorporating insights into continuous improvement initiatives.
Identifying opportunities for automation and integrating technological solutions to simplify compliance tasks and improve quality.
Lead and/or support continuous improvement initiatives to enhance productivity, quality, and customer deliverables.
Collaborate with key stakeholders to ensure global consistency, governance, and compliance with our training and procedures.
Culture and Behaviors Foster a collaborative and inclusive environment within GMM and other departments to create multidisciplinary approach to compliance, leveraging diverse perspectives for improvement.
Lead by example, embodying the highest standards of compliance behavior, and inspiring others.
Promote transparency in the compliance processes, decision making, and reporting, building trust.
Emphasize the importance of leadership, teamwork, ethical conduct, and adaptability in maintaining a robust compliance and quality culture within the team.
Demonstrate resilience in the face of challenges, maintaining composure and guiding the team through periods of change.
Cross-site coordination - Coordinate compliance across multiple sites or location, ensuring consistency in practices and adherence to global compliance standards.
Qualifications: Must-Have Bachelor's degree and relevant experience across supply chain, materials management, quality, compliance and GMP disciplines. OR 20 years direct experience.
Strong or emerging leadership skills.
Ability to work independently at a high level.
Strong interpersonal skills and accountability in day-to-day interactions with an operational focus on business goals, quality, and compliance.
Nice-to-Have Experience working in Quality, Drug Product Supply, Supply Chain, Materials Management within Pfizer.
Masters/Graduate Degree
Experience with data visualization software
PHYSICAL/MENTAL REQUIREMENTS
Primarily an office-based role involving sitting, walking, delivering presentations, active engagement with colleagues, customers, partners, etc.
The annual base salary for this position ranges from $83,500.00 to $139,100.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% of the base salary. 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.
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