Sr. Manager, Auditor

hace 3 semanas

Madrid, España Pfizer A tiempo completo

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 quality assurance team. You will be responsible for conducting Quality Assurance audits on GCP/GCLP Vendors supporting Pfizer QA audit strategy.

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.

It is your problem solving ability that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It- ROLE SUMMARY
- The Senior Manager, Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GxP/PV Vendors. This role is responsible for assuring the compliance of Vendors with standard processes, regulatory guidelines and laws (e.g. US FDA, EU Directives, ICH, and National regulations), business contracts and work orders, and an assessment of the protection of the rights, safety and well-being of study participants and consumers, as well as data privacy and security.
- ROLE RESPONSIBILITIES
- Assesses compliance of Vendors against applicable government agency GCP, GLP, GCLP, Regulatory and Pharmacovigilance regulations and guidelines as well as Pfizer policies and procedures
- Independently conducts/leads more complex routine audits for at least one vendor type (e.g. labs, study conduct, pharmacovigilance service providers), supports non-routine vendor audits and Pfizer process audits as applicable
- May engage with more complex audits or serve as a reviewer of low complexity, outsourced audits
- Leads RQA Vendor projects
- Supports and executes on quality programs related to functional areas, specific vendor entities and/or assessments
- Has GxP/PV working knowledge and is called upon to resolve issues based on knowledge of relevant SOPs (Standard Operating Procedures), GxP/PV regulations and guidelines, as well as local regulations
- Works with RQA colleagues on cross GxP/PV audit plans as required
- Provides clients with recommendations and influence to meet the changing business need with support from Manager

**Qualifications**:
Must-Have
- Bachelor's Degree
- 7+ years’ experience
- Experience supporting or leading Quality audits and developing/managing remediation plans
- Relevant pharmaceutical experience including previous Pharmacovigilance / clinical Quality Assurance experience conducting a broad range of audits
- Strong verbal and written communication including presentation skills
- Strong project management skills

Nice-to-Have
- Master's degree
- Experience in the pharmaceutical industry with preference for a diverse background encompassing operational risk and compliance management not only within QO but also experience in Operations, Validation, QC or other technical discipline
- Technical and practical knowledge of a variety of dosage forms

LI-PFE

Purpose

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
- The only available locations for new employees a

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