Use Your Power for Purpose
At Pfizer, we are committed to delivering medicines to the world with greater speed, without compromising on excellence and integrity. Navigating both local and global regulations is crucial, and the dynamic regulatory landscape demands innovative thinking and meticulous attention to detail. Your unwavering dedication and specialized knowledge will play a pivotal role in broadening and hastening patient access to Pfizer's medicines and vaccines. Your role will involve interpreting federal, state, and international regulations as they apply to our products, processes, practices, and procedures. You will investigate and resolve compliance issues both within and outside of Pfizer, ensuring that our commitment to excellence and integrity remains steadfast.
The Quality Oversight and Compliance Director is responsible for developing and maintaining Quality Plans, ensuring inspection and audit readiness, providing quality oversight of process deviations, investigations and associated corrective and preventive actions, and driving compliance of pan-regulatory (e.g. Manufacturing, Regulatory Strategy, CMC, Submissions, Clinical) information and processes globally.
The Quality Oversight and Compliance Director works to instil a quality mindset by ensuring the quality and compliance of regulatory processes and product/license information through clearly defined and documented metrics, identifying data trends and addressing associated process risks in collaboration with Regulatory Process Business Process Owners (BPOs) and stakeholders.
The Quality Oversight and Compliance Director works with Regulatory Process BPOs and stakeholders to identify and investigate procedural/compliance gaps and deviations, identify root cause and establish/monitor appropriate remediation plans through timely completion. The Quality Oversight and Compliance Director supports and drives implementation of inspection readiness, audit preparedness and training compliance
What You Will Achieve
1. Develop and lead/co-lead highly complex projects, creating mid-term plans that impact results and drive innovation.
2. Identify critical quality process parameters/KPIs to ensure data and process quality and collaborate to create associated Quality Plans and metric reports/dashboards.
3. Provide oversight of existing and input to planned processes/ systems /controls to ensure that quality is built-in to enable consistent compliance.
4. Identify procedural/compliance gaps associated with in scope processes and establishes mitigation and remediation plans with BPOs that provide optimal balance of compliance and business need.
5. Drive the investigation, remediation and closeout of Quality Events and associated corrective and preventive actions.
6. Drive and support inspection readiness activities and provide remediation support for audit (or inspection) findings.
7. Identify opportunities for improvement of pan-regulatory data and business processes and procedures through the definition, management and analysis of metric data in collaboration with BPOs and other stakeholders.
8. Leverage relationships to meet the needs of various business units, serving as an advisor and influencing management decisions.
9. Make decisions in complex problems, recommend innovative solutions, and support in solving issues impacting business units.
10. Act independently on self-initiated projects, using knowledge and judgment in complex decisions within business units.
11. Guide Pfizer by interpreting regulations and designing compliance programs, conducting audits, and evaluating policies.
12. Provide expertise on quality standards, support partner functions globally, and drive risk management and quality oversight.
Here Is What You Need (Minimum Requirements)
13. A BA/BS with at least strong experience or an MBA/MS with strong experience or a PhD/JD with experience or an MD/DVM with some experience
14. Profound knowledge of drug development, license maintenance processes, regulatory codes, guidance, and technologies
15. Experience with standard tools of continuous improvement and quality investigations, including DMAIC, root cause analysis, interview techniques and human performance analysis
16. Ability to present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment and provide consultation as a scientific/technical resource for assigned projects.
17. Familiarity with systems and electronic technologies that support regulatory activities
18. Ability to lead and operate seamlessly to influence colleagues across the organization andensure delivery to time and quality driving highly complex projects to meet evolving business needs and established deadlines.
19. Ability to work effectively within or lead a team in a matrix structure
20. Ability to influence without authority.
21. Proficiency in Microsoft Office
22. Strong analytical and problem-solving skills
23. Excellent written and verbal communication skills
Bonus Points If You Have (Preferred Requirements)
24. A Master's degree (MA/MBA/MS) with over 12 years of experience or a Doctorate (PhD/PharmD/JD) with more than 9 years of experience
25. Proficiency in Lean and/or Six Sigma methodologies
26. Experience in engaging with the external regulatory and pharmaceutical environment
27. A solid understanding of the business and financial landscape
28. Strategic thinking and the ability to develop innovative solutions
29. Experience in risk management and quality oversight
30. Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
Work Location Assignment: Hybrid
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
DisAbility Confident
We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!
Regulatory Affairs