L1 P&P Lead

Use Your Power for Purpose

• Colleague will support the management of the GMP Policy and Procedures Level 1 process grouping within the Quality Systems framework from end to end and provide global support to the PGS network.

• The document lifecycle includes interpreting regulations and ensuring requirements are captured with Global SOP documents. This is achieved by partnering with Global Process Owners to ensure clarity and obtain input on drafts.

• The colleague will partner with Regulatory Intelligence to review emerging regulations and ensure revisions to impacted Policies and Procedures are completed in a timely manner and ensure compliance with regulatory requirements.

• The colleague will also partner with the Internal Audit Data Integrity and Inspection Management team and with Regulatory Quality Assurance (Level 2 audit) to understand internal audit and inspectional observations CAPAs and trends to identify needed Policy and Procedure revisions.

• The colleague will participate on projects that drive process improvements within the Policy and Procedure team and across PGS.

• The individual will also participate in quality compliance network initiatives as needed act as change agent and help drive a mindset of continuous improvement.

What You Will Achieve

• Emerging regulation assessments for impact to global Quality Policies and Procedures

• Supporting the Global Process Owner throughout the Document lifecycle for Quality Policy Global SOPs and Work instructions including:

  • Identifying the need for revision

  • Authoring / Technical Writing

  • Continuous improvement loop

  • Socializing changes gathering feedback and closing the loop on communication of changes

  • Comment Gathering / Reconciliation

  • Approval

• Support Global Process Owner with global document deployment training and coaching.

• Manage the Policy and Procedure document change lifecycle. Revise/create Policy and Procedure documents assess changes for compliance accuracy and completeness and ensuring deliverables are realistic and timelines are met.

• Review emerging regulations and audit observations and determine potential impact to Policy and Procedures. Ensure needed revisions are completed according to timelines.

• Metrics and KPIs

• Develop training materials related to Quality Framework documents

• Coach PGS sites / functions to ensure appropriate application of Global requirements

• Participate on team projects focused on continuous improvement

• Actively participate in Process-related Communities of Practice (CoPs)

• Support other quality compliance initiatives in the PGS network as needed

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelors degree with at least 4 years of experience; OR a masters degree with at least 2 years of experience; OR a PhD with 0 years of experience; OR as associates degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience

• GMP experience in the pharmaceutical or medical device industry with preference for a diverse background. Must have expertise in quality systems /quality operations.

• Technical writing experience

• Understanding of current industry trends within Quality Systems

• Understanding of board of health requirements and ability to navigate the regulations

• Demonstrates leadership by constructively engaging with and providing PGS stakeholders with the best fit document content

• Excellent communication skills with the ability to build relationships influence outcomes and to deliver effective presentations to a variety of audiences

• Ability to work within tight timeframes and respond to changing requirements

• Demonstrated ability to interact effectively with all levels of management and colleagues

• Displays critical thinking expertise including qualitative/quantitative data to define and implement a strategic approach to developing risk-based content

• Self-motivated and flexible with the ability to work effectively in a dynamic problem-solving environment

• Experience with Microsoft Tools (e.g. SharePoint Excel Word)

• Fluent in English

Bonus Points If You Have (Preferred Requirements)

• Project management skills desired

PHYSICAL/MENTAL REQUIREMENTS

N/A Normal office environment and computer usage

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Ability to work flexible hours to occasionally accommodate sites / colleagues in different time zones (e.g. evening or morning teleconferences)

Occasional travel to a PGS site for meeting training or assist site

Work Location Assignment:Hybrid

The annual base salary for this position ranges from $96300.00 to $160500.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 12.5% 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 lifes 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 (). 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.

Quality Assurance and Control