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Documentation Manager

Employer
Pfizer
Location
Sanford, North Carolina
Salary
Competitive
Closing date
Jan 27, 2023

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Sector
Pharmaceutical, Regulatory Affairs
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional
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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 responsible for supporting the QA Document Management department in developing and implementing sustainable document management processes for a growing manufacturing site. Working in collaboration with the Senior Manager, Document Management, this individual will assist in executing a strategy focused on building robust document management processes in support of Pfizer Sanford's Vaccine and Gene Therapy Operations.

You will oversee day-to-day operation of the QA Document Management department and electronic systems, interface with other departments on site to ensure appropriate levels of service are being provided throughout the document lifecycle.You are focused on team building and collaboration, effective communication, change agility, and a high level of engagement to ensure success of the team.

It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Oversee daily operation of the site Document Management team; coach and develop team members to ensure flexibility of operations and improve engagement and individual colleague development
  • Develop work plans, schedules, and coordinates activities to ensure completion of assigned objectives. Contribute to development of site document management strategies for both long and short term
  • Implement effective communication and alignment between Document Management personnel and departments serviced across the site
  • Oversee deployment of IMEx accelerators and elements such as 5S, standard work, visual management, etc. in the Document Management department
  • Provide support or project management for site or corporate documentation initiatives
  • Lead efforts to implement continuous improvement and electronic systems
  • Participate in cross-functional teams to develop workable solutions for document management lifecycle; continuously review and improve Document Management SOPs, processes, and programs
  • Evaluate and/or oversee contractors or vendors


Qualifications

Must-Have
  • Bachelor's Degree with 5 years of relevant experience OR Master's Degree with 3 years of relevant experience OR Associate's Degree with 8 years of relevant experience OR High School Diploma or equivalent with 10 years of relevant experience
  • Experience working in a biopharmaceutical or regulated manufacturing facility
  • Able to quickly learn and navigate electronic systems to facilitate routine operation and maintenance of the site documentation system and related processes
  • A team player with strong interpersonal, organizational, and communications skills. The candidate must be self-motivated, engaged, and able to perform moderately complex tasks independently.
  • Experience working with GMP documentation


Technical Competencies

  • Strategic Planning
  • Communication and Presentation Skills
  • Analyzing needs
  • Decision making
  • Coaching
  • Meeting leadership /facilitation
  • Willingness to develop others
  • Willingness to establish networks (in site, across OpU / network)


Behavioral Competencies

  • Energy, enthusiasm & capability to drive change and commitment to challenge how we currently operate
  • Passion for continuous improvement and documentation
  • Excellent leadership, influencing, and interpersonal skills
  • Willingness to share ideas, to learn, and to be challenged


Physical/Mental Requirements

  • Position requirements are typical for an office-based work environment with the potential for some shop floor exposure.
  • Energy, enthusiasm & capability to drive change and commitment to challenge how we currently operate
  • Passion for continuous improvement and learning
  • Excellent leadership, influencing, and interpersonal skills
  • Willingness to share ideas, to learn, and to be challenged


Non-Standard Work Schedule, Travel or Environment Requirements

  • Schedule is primarily day shift but may require off-shift work on occasions.
  • The position may require working on the floor in manufacturing areas at times which will require a focus on safety.


Work Location Assignment:On Premise

Last day to apply: 25 January 2023

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

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.

Regulatory Affairs

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