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As a critical member of the site’s dedicated and highly effective Quality Systems Team, the Documentation Manager will be have sole accountability for day-to-day operation of the QA Document Management department and electronic systems. They interface with other departments on site to ensure appropriate levels of service are being provided throughout the document lifecycle.
The manager leads in setting the strategic direction for process improvements and the evolution of contemporary GMP documentation practices as operations progress further into paperless and enterprise driven environments. They will manage the complex integration of a paperless environment by ensuring the site is fully compliant with data integrity principles.
The Manager is integral part the Site’s Quality culture, they are responsible for ensuring all documentation practices meet GMP and Data Integrity standards, along with all health authority (HA) regulations. As well as, ensuring the site adheres to the performance metrics relating to documentation management.
In addition, the manager will lead and support reviews and ensure completion of critical site GMP documentation and coordinate the APRR/YBPR for the site’s products. Timely completion of the APRR/YBPR is critical to the site’s continued operations. All this documentation ensures the products quality and the site’s adherence to external health authority regulations.
- Collaborates with key internal and external partners to ensure the Site’s needs are met with corporate standards and enterprise system solutions (relative to document management).
- Provides strategic direction of the Site’s GMP records management program including document management enterprise system, document management procedures/workflows, records retention/archival philosophy and program, and performance monitoring.
- Active contributor within cross-functional teams on site and the network, developing workable solutions for document management lifecycle; continuously review and improve Document Management SOPs, processes, and programs
- Subject Matter Expert for the documentation systems, providing support to the site for documentation management, troubleshooting and maintenance
- Monitors and drives GMP documentation system performance to ensure sustainable compliance and enabling the attainment of commitments and Site’s Plan of Record.
- Responsible for ensuring sites adherence to documentation management related metrics, along with creation of suggestive metrics which will help the site have leading indicators on performance
- Fosters a culture of continuous improvement to include documentation process and procedures.
- Reviews and approves investigations, change controls, commitments, and procedures as they relate to the site’s operations
- Coordinates the completion of the APRR/YBPR which includes tracking completion of chapter reports and submitting reports and data on time.
- Leads in providing documentation during internal and regulatory site inspections, ensuring timely and accurate completion of document requests made by the auditors
- Oversee deployment of IMEx accelerators and elements such as 5S, standard work, visual management, etc. as it pertains to Document Management
- Provide support or project management for site or corporate documentation initiatives
- Lead efforts to implement continuous improvement and electronic systems to help build a robust documentation management program
- Responsible for mentoring and coaching others within the site and/or network (as applicable) on best practices for documentation management
- Responsible for leading/coaching on the implementation of PHP principles in document design
- Bachelor’s Degree in science discipline or other relevant field with 5 – 8 years of relevant experience in a regulated GMP environment OR MS in science discipline or other relevant field with a minimum of 3 years of relevant experience in a regulated GMP environment.
- Demonstrated management experience, either through direct people leadership or significant project management experience.
- Knowledge of GMP regulations/guidances (21 CFR Parts 11, 210 &211; EC Annex 15; ICH 7) as they pertain to the pharmaceutical/biopharmaceutical industry.
- A team player with strong interpersonal, organizational, and communications skills are a must. Additionally, the candidate must be self-motivated, engaged and able to perform moderately complex tasks independently.
- A broad understanding of Biopharmaceutical Sciences processes and Quality Systems
- Proficiency with basic business analysis tools such as process mapping, decision flowcharting, DMAIC, etc.)
- Excellent communication skills including technical writing and presentation development and delivery
- Proficient in data integrity principles and management of electronic records
- Strategic Planning
- Decision making
- Coaching/development of others
- Willingness to establish networks (in site, across OpU / network)
- This position will spend significant time in an office type setting as well as attending cross functional meetings.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- May require support for site as needed beyond core business hours.
- Little to no travel required.
OTHER JOB DETAILS
- Last Date to Apply for Job: April 7th, 2022
- Eligible for Relocation Package – NO
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.
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.