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Quality Risk Management Manager

Employer
Pfizer
Location
Kalamazoo, Michigan
Start date
Aug 5, 2022

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Discipline
Quality, Quality Control
Required Education
High School or equivalent
Position Type
Full time
Hotbed
Best Places to Work
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Job Details

Why Patients Need You

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.

This position provides leadership and direction for Quality Risk Management program at Kalamazoo Site. Aligns site QRM practices with Pfizer standards and Regulatory Guidance documents. Works with teams of SME colleagues to complete QRM to define/support site practices. Develops and maintains QRM tools and infrastructure to address emerging compliance and organizational needs.

How You Will Achieve It

  • Manage Quality Risk Management (QRM) program for Site to assure compliance to both Pfizer and Regulatory standards.

  • Provide guidance and direction to QRM teams and leaders to assure consistent application of QRM principles.

  • Design and implement QRM tools to address full range of emerging needs and applications.

  • Maintain QRM library and other databases, including lifecycle management of approved QRMs.

  • Support QRMs during audits. Provide strategic direction for responses to audit QRM concerns.

  • Maintain and lead Site QRM training program

  • Consult and align with other Sites on QRM programs

Qualifications

Must-Have

  • Applicant must have HS Diploma with ten years of relevant experience;

  • OR an Associate's degree with eight years of experience;

  • OR a Bachelor’s degree with at least five years of experience;

  • OR a Master’s degree with more than three years of experience;

  • OR a Ph.D. with 0-2 years of experience.

  • Demonstrated ability in developing scientific reasoning and problem solving with minimal coaching, as well as excellent written and oral communication skills.

  • Also have excellent negotiation skills, and will be able to frequently resolve issues with a focus on quality risk management. They will have demonstrated skill in developing solutions, and will do so with a flexible approach to the development of options.

Nice-to-Have

  • Experience with like industry-related quality risk management

Other Job Details

  • Last Date to Apply: August 12, 2022
  • Eligible for Relocation Package: YES

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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