Quality Oversight and Compliance Director in Stone

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.

Responsibilities include:

• Developing and maintaining Quality Plans, ensuring inspection and audit readiness.
• Providing quality oversight of process deviations, investigations and associated corrective and preventive actions.
• Driving compliance of pan-regulatory information and processes globally.
• Developing and leading/co-leading highly complex projects, creating mid-term plans that impact results and drive innovation.
• Identifying critical quality process parameters/KPIs to ensure data and process quality and collaborating to create associated Quality Plans and metric reports/dashboards.
• Providing oversight of existing and input to planned processes/systems/controls to ensure that quality is built-in to enable consistent compliance.
• Identifying procedural/compliance gaps associated with in scope processes and establishing mitigation and remediation plans with BPOs.
• Driving the investigation, remediation and closeout of Quality Events and associated corrective and preventive actions.
• Driving and supporting inspection readiness activities and providing remediation support for audit (or inspection) findings.
• Identifying opportunities for improvement of pan-regulatory data and business processes and procedures through the definition, management and analysis of metric data.
• Leveraging relationships to meet the needs of various business units, serving as an advisor and influencing management decisions.
• Making decisions in complex problems, recommending innovative solutions, and supporting in solving issues impacting business units.
• Guiding Pfizer by interpreting regulations and designing compliance programs, conducting audits, and evaluating policies.
• Providing expertise on quality standards, supporting partner functions globally, and driving risk management and quality oversight.

Here Is What You Need (Minimum Requirements):

• 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.
• Profound knowledge of drug development, license maintenance processes, regulatory codes, guidance, and technologies.
• Experience with standard tools of continuous improvement and quality investigations, including DMAIC, root cause analysis, interview techniques and human performance analysis.
• 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.
• Familiarity with systems and electronic technologies that support regulatory activities.
• Ability to lead and operate seamlessly to influence colleagues across the organization and ensure delivery to time and quality.
• Ability to work effectively within or lead a team in a matrix structure.
• Ability to influence without authority.
• Proficiency in Microsoft Office.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.

Bonus Points If You Have (Preferred Requirements):

• 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.
• Proficiency in Lean and/or Six Sigma methodologies.
• Experience in engaging with the external regulatory and pharmaceutical environment.
• A solid understanding of the business and financial landscape.
• Strategic thinking and the ability to develop innovative solutions.
• Experience in risk management and quality oversight.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot.

Work Location Assignment: Hybrid

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.

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.

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.

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.