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Job Information

Pfizer PSQA Quality Risk Strategic Process Lead in Groton, Connecticut

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 a member of Pfizer's dedicated and highly effective PharmSci Quality Assurance Team. You will be responsible for the Quality Risk Management strategy in the PharmSci organization based on ICH Q9, Pfizer PQS and PharmSci procedures in support of complex and lightspeed projects. This Quality position is considered a global position and reports into the Compliance Center of Excellence Lead as part of a team responsible for the management, performance, advancement and oversight of the Quality Management System across the global Pharmaceutical Sciences Organization. This role plays a key part in bringing life changing products to our patients in a fast-paced and change agile work environment and

will help in fostering the achievement of the company's mission globally.

As a Senior Manager, your advanced knowledge of the principles and concepts in the discipline and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. Your ability to develop and manage plans will facilitate in achieving objectives, interpreting internal and external business challenges and recommending best practices for improvements. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for the division.

How You Will Achieve It

  • Lead and support execution of Quality Risk Management strategic plan

  • Analyze data to support QRM compliance, strategic plan

  • Lead and support Audit and Inspection readiness efforts for quality risk management

  • Lead the QRM Community of Practice and provide stakeholder management and communications for quality risk management activities and changes

  • Provides regular reporting and results to quality councils, management teams and stakeholders

  • Develop, manage and plan to achieve objectives, help drive process improvements and adoption of global best practices

  • Identify areas to improve QRM process operational efficiency, effectiveness, and integration with regards to end to end drug development processes

  • Develop culture of quality risk management across Pharmaceutical Sciences and related stakeholders

  • Analyze metrics and feedback for opportunities to improve effectiveness and align with process and stakeholder needs

  • Ensure that business utilization of QRM-process related systems is effective and efficient to achieve the desired strategic outcome

  • Responsible for monitoring and support of the performance of QRMs and identifying ways to improve the process in accurately assessing risk (for example automation, logic or pattern recognition software)

  • Actively monitors and maintains industry-wide expertise of QRM

Qualifications

Must-Have

  • Bachelor's Degree in a scientific related discipline

  • 7+ years' experience with GMP, Quality, and risk management in a pharmaceutical environment and/or highly regulated industry

  • Expertise in ICH Q9 and multiple QRM tools eg - FMEA, FTA, HAZOP

  • Must have expert knowledge in global quality trends

CORE COMPETENCIES

  • Experience working across multiple levels in an organization

  • Diverse leadership experiences and capabilities including ability to influence and collaborate with peers, develop and coach others, and create business impact

  • Strong written and verbal communication skills in relating to leaders, colleagues and associates both inside and outside the organization

  • Experience using data to drive solutions to business challenges

  • Experience delivering results in a highly matrixed organization

  • Strong facilitation and presentation skills

  • Able to work effectively across divisional, functional, site and vendor boundaries

  • Able to work in ambiguous situations to identify and resolve complex problems

  • Excellent collaborator able to partner across stakeholders

  • Contributes to a learning environment by sharing knowledge and best practices within and across the organization

  • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Nice-to-Have

  • Master's degree in a scientific related discipline

  • Project management and continuous improvement experience

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. Role is primarily office-sitting, standing, walking, and bending.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Standard 40-hour workday

Additional Position Details

  • Last Date to Apply: Nov 5, 2021

  • Location Details - Position primarily remote; preferably at a Pfizer Pharm-Sci facility

  • Relocation Assistance NOT provided

  • Eligible for Employee Referral Bonus

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.

Quality Assurance and Control

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