Manager-Quality Risk and Knowledge Management

Use Your Power for Purpose

Every day our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible innovative and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development maintenance compliance or analysis through research programs your contribution directly impacts patients.

ROLE SUMMARY:

The Manager Quality Risk and Knowledge Management will report to the Risk and Knowledge Management Review Lead within the Quality Systems and Compliance team.

This role is responsible for supporting the global processes for PGS Quality Risk Management and Knowledge Management in accordance with CI initiatives industry expectations and regulatory requirements. The role will accomplish this by supporting the development and execution of harmonized and standardized practices and systems across the product lifecycle from product development through product discontinuation.

ROLE RESPONSIBILITIES

• Provide Quality Risk Management (QRM)expertise to support the network
• Support the development of risk tool approaches within different Quality Management System (QMS) processes with limited supervision
• Partner with the Knowledge Management Lead and digital team on the assessment of E-Systems to manage and/or connect product data
• Lead QRM technical expertise for the configuration and administration of electronic QMS (eQMS) for QRM
• Effectively collaborates and communicates with middle management levels to ensure local and global processes are well defined and opportunities for continual improvement are explored
• Creates supporting documents as defined
• Supports deliverables pertaining to the QRM and Knowledge Management training strategies (procedures risk tools Quality by Design)
• Member of the global QRM Process Centric Team and Knowledge Management network to share knowledge and best practices
• Facilitates critical complex risk assessments as needed
• Co-Lead or participate in small-medium scale transversal projects to support Global Quality initiatives as assigned

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
• Experience in quality assurance and/or business process experience in the medical device biotech and/or pharmaceutical industry
• Strong experience with the use of risk management tools (FMEA HACCP process mapping and root cause analysis tools)
• Project Management experience involving proven capability to strategize collaborate and execute on the successful completion of process improvements (small-med scale)
• Good understanding and practical use of ICH ISO and cGMP regulations
• Proven critical thinking skills to be able to connect GxP requirements with business processes and understand potential impacts
• Strong collaboration skills and proven experience in working transversally
• Teach and present new ideas with clarity and simplicity
• Able to work in and adapt to ambiguous situations to identify and resolve complex problems
• Proactive mindset

Bonus Points If You Have (Preferred Requirements)

• Knowledge of data and reporting systems experience using data to drive decisions and provide solutions to business challenges
• Contributes to a learning environment by sharing knowledge and best practices within and across the organization

PHYSICAL/MENTAL REQUIREMENTS

Mental agility to handle a broad scope of different types of quality assurance work (e.g. data analysis communication often virtually 1:1 and with larger groups). Ability to independently problem-solve and make recommendations for solutions. The role is primarily office-sitting standing walking and bending.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Standard 40-hour work week limited travel - domestic and internationally (10%)

Schedule is primarily day shift but may require off-shift work on occasions.

Work Location Assignment:Remote

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