Director Compliance & Systems

Pfizer • Kalamazoo, MI

18h • Onsite

About The Position

Use Your Power for Purpose Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is flexible, innovative, and customer-oriented. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of our work. What You Will Achieve In this role, you will: Ensure compliance with applicable laws, regulations, and policies, providing guidance and advice on compliance issues to senior management. Oversee and manage compliance programs and initiatives while developing and leading/co-leading highly complex projects. Lead strategic direction, business performance, and financial management for complex activities within a Division or Global Business Unit, ensuring alignment with overall company goals. Manage people, technology, and financial resources, including leveraging resources outside of direct authority, to achieve Division or Global Business Unit objectives. Foster a culture of continuous improvement and innovation, encouraging acceptable risk-taking and developing solutions to complex problems. Contribute to strategy development and execution, influencing senior management decisions and setting long-term direction for the Division or Global Business Unit. Oversee talent and leadership development, participate in succession planning, and ensure senior managers are accountable for skill development and diversity. Develop and maintain quality programs, processes, and procedures to ensure compliance with established standards and agency guidelines, and ensure preparedness for audits and inspections. Implement strategic actions based on industry knowledge, customer requirements, and the general business environment, and interpret the division's strategy to establish business priorities. Define, develop, and deliver strategies and operational plans for quality control, incorporating continuous improvement methodologies and tools across Worldwide Strategy and Regulatory processes. Provide support to Global Quality Operations programs, Materials Supply Quality Assurance, and other related areas, representing Supply Chain Market & Market Quality Operations on relevant initiatives and teams. Maintain a comprehensive understanding of company policies, worldwide regulations, and guidelines impacting safety data management, reporting, and pharmacovigilance, supporting business growth and development in respective markets. Here Is What You Need (Minimum Requirements) Applicant must have a bachelor's degree with at least 8 years of experience; OR a master's degree with at least 7 years of experience; OR a PhD with 5 years of experience. Strong background in Pharmacovigilance, Regulatory Affairs, or within a Health Authority Proven ability to lead intricate projects and cross-functional processes, ensuring deadlines are met Cultivates effective relationships with key internal and external customers and stakeholders Strong people management skills Experience in quality risk management, tracking commitments, interpreting policies, managing site complaints, and providing process analyses oversight Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Requirements

• Applicant must have a bachelor's degree with at least 8 years of experience; OR a master's degree with at least 7 years of experience; OR a PhD with 5 years of experience.
• Strong background in Pharmacovigilance, Regulatory Affairs, or within a Health Authority
• Proven ability to lead intricate projects and cross-functional processes, ensuring deadlines are met
• Cultivates effective relationships with key internal and external customers and stakeholders
• Strong people management skills
• Experience in quality risk management, tracking commitments, interpreting policies, managing site complaints, and providing process analyses oversight
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Nice To Haves

• Experience in the pharmaceutical industry
• Knowledge of international compliance regulations
• Advanced degree in law or related field
• Experience with regulatory agencies
• Demonstrated success in influencing senior management
• Ability to navigate complex legal and regulatory environments
• Exceptional strategic thinking and planning skills
• Strong interpersonal and relationship-building skills
• Effective organizational and time management abilities

Responsibilities

• Ensure compliance with applicable laws, regulations, and policies, providing guidance and advice on compliance issues to senior management.
• Oversee and manage compliance programs and initiatives while developing and leading/co-leading highly complex projects.
• Lead strategic direction, business performance, and financial management for complex activities within a Division or Global Business Unit, ensuring alignment with overall company goals.
• Manage people, technology, and financial resources, including leveraging resources outside of direct authority, to achieve Division or Global Business Unit objectives.
• Foster a culture of continuous improvement and innovation, encouraging acceptable risk-taking and developing solutions to complex problems.
• Contribute to strategy development and execution, influencing senior management decisions and setting long-term direction for the Division or Global Business Unit.
• Oversee talent and leadership development, participate in succession planning, and ensure senior managers are accountable for skill development and diversity.
• Develop and maintain quality programs, processes, and procedures to ensure compliance with established standards and agency guidelines, and ensure preparedness for audits and inspections.
• Implement strategic actions based on industry knowledge, customer requirements, and the general business environment, and interpret the division's strategy to establish business priorities.
• Define, develop, and deliver strategies and operational plans for quality control, incorporating continuous improvement methodologies and tools across Worldwide Strategy and Regulatory processes.
• Provide support to Global Quality Operations programs, Materials Supply Quality Assurance, and other related areas, representing Supply Chain Market & Market Quality Operations on relevant initiatives and teams.
• Maintain a comprehensive understanding of company policies, worldwide regulations, and guidelines impacting safety data management, reporting, and pharmacovigilance, supporting business growth and development in respective markets.

Benefits

• eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20,0% of the base salary and eligibility to participate in our share based long term incentive program
• 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
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Director