Operations Compliance Lead

Pfizer

Sanford, Massachusetts

JOB DETAILS
SKILLS
Analysis Skills, Artificial Intelligence (AI), Communication Skills, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Environmental Regulations, FDA (Food and Drug Administration), Federal Laws and Regulations, Government, Healthcare Providers, Identify Issues, Incentive Programs, Interpersonal Skills, Leadership, Maintain Compliance, Microsoft Product Family, Organizational Skills, Patient Care, People Management, Policy Implementation, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Project/Program Management, Quality Assurance, Quality Management, Regulations, Risk, Risk Analysis, Risk Management, Root Cause Analysis, Safety Standards, Safety/Work Safety, State Laws and Regulations, Strategic Planning, Willing to Travel, Writing Skills
LOCATION
Sanford, Massachusetts
POSTED
5 days ago

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, rooted in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or research analysis, your contributions are vital and directly impact 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. As the Director of Quality Assurance within the Global Supply division, you will play a pivotal role in improving patients' lives by ensuring the highest standards of quality and safety in our products. Your leadership and expertise will drive the growth of our Quality Assurance team, fostering a culture of innovation and excellence that directly impacts the well-being of patients worldwide.

What You Will Achieve

In this role, you will:

  • Develop and lead/co-lead highly complex projects, creating mid-term plans that impact results.

  • Leverage relationships to meet the needs of various business units, serving as an advisor to others.

  • Make decisions in complex problems, identifying innovative solutions, and recommending courses of action that influence management and senior staff decisions.

  • Act independently on self-initiated projects, utilizing knowledge from others and exercising judgment in complex decisions.

  • Review work for effectiveness and business impact, and evaluate the work of colleagues.

  • Exercise foresight and judgment using knowledge and experience within the business unit.

  • Develop innovative ideas and lead complex business unit projects.

  • Act as an enterprise leader in Quality, partnering with business leadership to develop and strengthen a holistic Quality Management System.

  • Innovate to create new strategies and solutions that improve the business unit's value and contribution to the enterprise.

  • Partner with cross-functional leadership to develop strategies, identify risks, provide guidance, and oversee mitigations across global functions.

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

  • Proven technical knowledge and expertise in root cause analysis (RCA) and CAPA activities

  • Demonstrated in-depth understanding of global regulations, guidelines, and evolving legislation

  • Excellent organizational, analytical, strategic, interpersonal, written, and oral communication skills

  • Thorough understanding and application of cGMP principles, relevant quality processes, systems, and Country Specific Standards

  • Experience in developing and leading complex projects and mid-term plans

  • Ability to make decisions in complex problems and identify innovative solutions

Bonus Points If You Have (Preferred Requirements)

  • Proficiency in engaging with FDA, EU investigators, and other regulatory bodies during audits

  • Profound grasp of compliance and quality management, including the necessary procedures and audit readiness requirements

  • Extensive experience within regulated environments, encompassing policies, procedures, and processes

  • Strong leadership and team-building skills

  • Ability to influence and partner with cross-functional leadership

  • Excellent problem-solving and decision-making abilities

  • Strong project management skills

  • Ability to foster a culture of innovation and continuous improvement

  • 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

  

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

20% Travel


Work Location Assignment: Hybrid

The annual base salary for this position ranges from $176,600.00 to $294,300.00. In addition, this position is 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. 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. This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

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.

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email 

disabilityrecruitment@pfizer.com

. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Quality Assurance and Control

About the Company

P

Pfizer

A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
COMPANY SIZE
5,000 to 9,999 employees
INDUSTRY
Biotechnology/Pharmaceuticals
FOUNDED
1849
WEBSITE
http://www.pfizer.com