Quality Management System (QMS) Coordinator

Pfizer•Groton, CT

4d•Hybrid

About The Position

Use Your Power for Purpose Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. What You Will Achieve The QMS Coordinator will support Pfizer Global Supply (PGS) Quality Management System (QMS) by coordinating document lifecycle, translations, and training materials within the Quality Management System (QMS) framework. This role ensures compliance with Good Manufacturing Practices (GMP) and global quality standards, enabling accurate documentation control, multilingual accessibility, and effective training material delivery QMS Coordinator’s responsibilities are split into three key areas. 1.Project Management Establish optimized Global document (GSOP, GWI, etc.), training materials and associated translation timelines which reflect project timelines and interdependencies across competing resources and workstreams (Document Management, Training, Concurrent Process Deployments, Translation Reviewer availability and Translation Vendor capacity and global calendars). Adhere to established translation budget, escalate budget concerns to Project Management Office. Serve as primary communicator of risks to on-time completions to applicable levels within the organization to ensure timely mitigation and or necessary timeline adjustments. Follow the effective document management process to maintain compliance during creation of new and revision of existing documents and applicable training materials requiring translation. 2.Translation System Administration Serve as the Subject Matter Expert (SME) of the Pfizer global translation platform (currently VOX PRO) with a thorough understanding of each role: Submitter, Post-Editor, and Reviewer. Complete required Submitter role training and submit documents and training materials for translation through internal and external workflows adhering to the RSL providing scope and identified reviewers. 3. End-to-End Continuous Improvement Apply a continuous improvement mindset to challenge the status quo of the document lifecycle process to refine and improve the end-to-end process and impacted colleague experience. Establish feedback loop with key partners (Document Management/Training Team/ Vox Pro Digital Team). Here Is What You Need (Minimum Requirements) Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with more than 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience Familiarity with document control systems and training development and deployment. Self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment Fluent in English Project Management skills Strong organizational and coordination skills Excellent communication and attention to detail Bonus Points If You Have (Preferred Requirements) Proficiency in QMS platforms (e.g., Veeva, Documentum), translation tools (e.g VOXPro) and Learning Management systems 3+ years in pharmaceutical or regulated industry with QMS experience. Demonstrated ability to learn and master new applications software Strong analytical and problem-solving skills Strong project management skills Effective communication and collaboration skills PHYSICAL/MENTAL REQUIREMENTS Office role, ability to work in teams and participate in Live Teams Calls on camera NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS None OTHER JOB DETAILS Last Date to Apply for Job: 1/9/26 Work Location Assignment: Hybrid The annual base salary for this position ranges from $80,300.00 to $133,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. 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. 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. 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 [email protected]. 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. Quality Assurance and Control 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 bio pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Requirements

Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with more than 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience
Familiarity with document control systems and training development and deployment.
Self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment
Fluent in English
Project Management skills
Strong organizational and coordination skills
Excellent communication and attention to detail

Nice To Haves

Proficiency in QMS platforms (e.g., Veeva, Documentum), translation tools (e.g VOXPro) and Learning Management systems
3+ years in pharmaceutical or regulated industry with QMS experience.
Demonstrated ability to learn and master new applications software
Strong analytical and problem-solving skills
Strong project management skills
Effective communication and collaboration skills

Responsibilities

Establish optimized Global document (GSOP, GWI, etc.), training materials and associated translation timelines which reflect project timelines and interdependencies across competing resources and workstreams (Document Management, Training, Concurrent Process Deployments, Translation Reviewer availability and Translation Vendor capacity and global calendars).
Adhere to established translation budget, escalate budget concerns to Project Management Office.
Serve as primary communicator of risks to on-time completions to applicable levels within the organization to ensure timely mitigation and or necessary timeline adjustments.
Follow the effective document management process to maintain compliance during creation of new and revision of existing documents and applicable training materials requiring translation.
Serve as the Subject Matter Expert (SME) of the Pfizer global translation platform (currently VOX PRO) with a thorough understanding of each role: Submitter, Post-Editor, and Reviewer.
Complete required Submitter role training and submit documents and training materials for translation through internal and external workflows adhering to the RSL providing scope and identified reviewers.
Apply a continuous improvement mindset to challenge the status quo of the document lifecycle process to refine and improve the end-to-end process and impacted colleague experience.
Establish feedback loop with key partners (Document Management/Training Team/ Vox Pro Digital Team).

Benefits

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
health benefits to include medical, prescription drug, dental and vision coverage

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