Quality Management Specialist

We're in relentless pursuit of breakthroughs that change patients' lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer's purpose – Breakthroughs that change patients' lives – we have established a clear set of expectations regarding "what" we need to achieve for patients and "how" we will go about achieving those goals.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Transforming Delivery of high quality products

PGS - Manufacture the Future

The Quality Management Specialist will be r eporting to the Global Clinical Supply (GCS) Manila Operations Team Lead , with a matrix reporting relationship to the Inspection and Risk Management ( IRM ) Senior Director . The GCS IRM Group instills concepts of Risk Management and Inspection Readiness throughout GCS to ensure that clinical trial project work is conducted to internal and external standards and can withstand Regulatory Inspection.

The GCS Quality Management Specialist role will provide support for inspection readiness and pre-inspection preparations for global inspections. The role involves interaction with GCS colleagues and contractors to ensure state of program inspection readiness at all times .

ROLE RESPONSIBILITIES

Responsibilities include the following:

Inspection Readiness

Initiate inspection readiness tools, such as GCS Inspection Readiness Storyboard .

W ork with IRM Inspection Readiness Lead and the Clinical Supply Teams to ensure inspection readiness tools are finalized .

Manage inspection readiness trackers .

Support pre-inspection preparation for global inspections ( e.g., notifications, Teams channels, documents, presentations ) .

Support collection of pre-inspection documentation for inspections conducted in Asia ( i.e., Japan, China, Taiwan ) .

Review and trigger prompts for updates to GCS Risk, Decision, Roster tool.

Ensure information provided during inspections are appropriately archived once inspection is complete .

Utilize and share learnings, perform lessons learnt from inspections to advance quality culture.

Quality Management

Update Teams and SharePoint sites accordingly .

Participate in trend analysis and lessons learned and proactively share and manage components relating to GCS .

Perform data analysis and trending, generate presentations, and present findings ( e.g . , IRM quarterly metrics ) .

Escalate concerns to Head of GCS Inspection and Risk Management and PharmSci OQ related to timelines, engagement, and quality.

Work in collaboration with GCS functional lines and PharmSci OQ to manage and deliver responsibilities.

Use data applications to surface, highlight, manage and share information to improve quality across GCS in functional line meetings, lesson learned .

Basic Qualifications :

Bachelor's Degree

3+ years of pharmaceutical experience with solid experience in clinical studies, investigational supplies, supply chain, GMP/GCP Quality

Demonstrated organizational and project management skills

Demonstrated strength in analytical skills and attention to detail

Good understanding of relevant regulatory and audit frameworks that apply to the biopharmaceutical operations

Ability to manage multiple complexprojects and has business acumen

Excellent interpersonal effectiveness and written and verbal communication skills

Technical proficiency , including skills in use of common desktop tools (MS Word, MS Excel, MS Project, Visio); Office365 and SharePoint; tools for analysis and graphing and reporting (Spotfire)

Preferred Qualifications:

Ability to progress work activities with oversight

Regulatory inspection experience

Knowledge of clinical trial processes and relationships

Knowledge of GCP requirements and applicable SOPs and regulations

Project management, administrative, and technical capabilities

Strong and effective verbal and written communication skills

Quality or compliance experience

Scientific background in Life Sciences, Regulatory Affairs

Strong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlines

Ability to adapt to changing situations and work well under pressure

Speak/read Japanese and/or Chinese

PHYSICAL/MENTAL REQUIREMENTS

Office work only

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Will periodically require working across US, EU, Asia hours to support regulatory activity and/or engagement with global colleagues.

Hybrid Set Up

#LI-PFE

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

The Quality Management Specialist will be r eporting to the Global Clinical Supply (GCS) Manila Operations Team Lead , with a matrix reporting relationship to the Inspection and Risk Management ( IRM ) Senior Director . The GCS IRM Group instills concepts of Risk Management and Inspection Readiness throughout GCS to ensure that clinical trial project work is conducted to internal and external standards and can withstand Regulatory Inspection.

The GCS Quality Management Specialist role will provide support for inspection readiness and pre-inspection preparations for global inspections. The role involves interaction with GCS colleagues and contractors to ensure state of program inspection readiness at all times .

ROLE RESPONSIBILITIES

Responsibilities include the following:

Inspection Readiness

• Initiate inspection readiness tools, such as GCS Inspection Readiness Storyboard .
• W ork with IRM Inspection Readiness Lead and the Clinical Supply Teams to ensure inspection readiness tools are finalized .
• Manage inspection readiness trackers .
• Support pre-inspection preparation for global inspections ( e.g., notifications, Teams channels, documents, presentations ) .
• Support collection of pre-inspection documentation for inspections conducted in Asia ( i.e., Japan, China, Taiwan ) .
• Review and trigger prompts for updates to GCS Risk, Decision, Roster tool.
• Ensure information provided during inspections are appropriately archived once inspection is complete .
• Utilize and share learnings, perform lessons learnt from inspections to advance quality culture.

Quality Management

• Update Teams and SharePoint sites accordingly .
• Participate in trend analysis and lessons learned and proactively share and manage components relating to GCS .
• Perform data analysis and trending, generate presentations, and present findings ( e.g . , IRM quarterly metrics ) .
• Escalate concerns to Head of GCS Inspection and Risk Management and PharmSci OQ related to timelines, engagement, and quality.
• Work in collaboration with GCS functional lines and PharmSci OQ to manage and deliver responsibilities.
• Use data applications to surface, highlight, manage and share information to improve quality across GCS in functional line meetings, lesson learned .

Basic Qualifications :

• Bachelor's Degree
• 3+ years of pharmaceutical experience with solid experience in clinical studies, investigational supplies, supply chain, GMP/GCP Quality
• Demonstrated organizational and project management skills
• Demonstrated strength in analytical skills and attention to detail
• Good understanding of relevant regulatory and audit frameworks that apply to the biopharmaceutical operations
• Ability to manage multiple complexprojects and has business acumen
• Excellent interpersonal effectiveness and written and verbal communication skills
• Technical proficiency , including skills in use of common desktop tools (MS Word, MS Excel, MS Project, Visio); Office365 and SharePoint; tools for analysis and graphing and reporting (Spotfire)

Preferred Qualifications:

• Ability to progress work activities with oversight
• Regulatory inspection experience
• Knowledge of clinical trial processes and relationships
• Knowledge of GCP requirements and applicable SOPs and regulations
• Project management, administrative, and technical capabilities
• Strong and effective verbal and written communication skills
• Attention to detail
• Quality or compliance experience
• Scientific background in Life Sciences, Regulatory Affairs
• Strong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlines
• Ability to adapt to changing situations and work well under pressure
• Speak/read Japanese and/or Chinese

PHYSICAL/MENTAL REQUIREMENTS

Office work only

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Will periodically require working across US, EU, Asia hours to support regulatory activity and/or engagement with global colleagues.

Hybrid Set Up

#LI-PFE

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer's purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.

Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:

"Breakthroughs" - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.

"Change" - We want to do more than simply improve patients' medical conditions; we want to dramatically change their lives for the better.

"Patients' lives" - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It's an intentionally holistic view.

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.

To fully realize Pfizer's purpose, we have established a clear set of expectations regarding "what" we need to achieve for patients and "how" we will go about achieving those goals.

The "how" is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.

Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.

Excellence: We can only change patients' lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.

Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.

Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.

With an unwavering commitment to innovation, we use a multidisciplinary approach that blends scientific expertise, cutting-edge technologies, and strategic collaborations, igniting a powerful engine that propels groundbreaking discoveries into life-saving treatments for patients in need.

Through our relentless pursuit of progress, we envision a future where cutting-edge medicines pave the way to healthier, happier lives worldwide.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.

Our Competitive Benefits Programs help our colleagues by:

• Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing . Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
• Strengthening Colleagues' Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
• Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it's a child, spouse or parent, bereavement leave, and additional country-specific programs.
• And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers , movement and mindfulness solutions, "Log in for your Day" work flexibility and so much more.