Senior Quality and Compliance Analyst

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight. Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on to ensure that the quality assurance programs and policies are maintained and modified regularly. You will make sure that there are uniform standards worldwide and best practice sharing, which will help in fostering the achievement of the company’s mission globally.

As a Senior Quality and Compliance Analyst, your advanced knowledge of the principles and concepts in the discipline and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. Your ability to develop and manage plans will facilitate in achieving objectives, interpreting internal and external business challenges and recommending best practices for improvements. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for the division.

How You Will Achieve It

• Develop ideas and lead/co-lead complex projects across the business unit.
• Develop, manage and plan to achieve objectives, help drive process improvements and adoption of global best practices.
• Facilitate and/or support the development and implementation of medical device and combination product quality governance processes.
• Communicate relevant quality, Environment, Health and Safety, and business information to the facility / supplier / contract manufacturer in an effort to maintain and enhance the relationship between the audited entity and Pfizer.
• Drive the Medical Quality program and strategies and overall culture of Quality within the region, in partnership with relevant stakeholders.
• Develop and drive the local compliance program in consultation with Country Management and Regional Compliance, through preparation of an annual compliance operating plan addressing the risk profile of the market.
• Assess adherence to relevant regulatory Good Manufacturing Practices {also cGMP} guidance documents, Pfizer Quality Standards, Functional and local SOPs and Pfizer expectations.
• Identify and analyze enterprise Good Clinical Practices {part of GxP} quality risks and opportunity areas.
• Performs gap assessments of processes and procedures against relevant device regulations.
• Provide support, where required, to the Regulatory Inspection Response Director in developing responses to regulatory inspection observations.
• Perform initial agency and site intelligence to enable better focus for audits and inspection preparation.
• Provide training on subject matter expertise areas as needed.

Qualifications

Must-Have

• Bachelor’s Degree with 7+ years’ of relevant experience.
• Demonstrated experience leading successful medical device and combination products compliance optimization activities
• Diverse leadership experiences and capabilities including ability to influence and collaborate with peers, develop and coach others, and create business impact
• Detailed knowledge of clinical trial operational processes and supporting systems and tools
• Finance awareness and ability to develop training budget estimates and justify costs
• Strong project management, organization and planning skills
• Strong written and verbal communication skills

Nice-to-Have

• Master’s degree
• Relevant pharmaceutical experience
• Project management and continuous improvement experience
• Experience working closely with a relevant regulator

Other Job Details:

• Last Date to Apply for Job: February 5th, 2023.
• Work Location Assignment: On Premise

  On Premise colleagues work in a Pfizer site because it’s needed to get their job done. They may have flexibility to work remotely from time to time, but they are primarily on-site.

The annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% 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 un-jobs.net (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.

Quality Assurance and Control