External Site Ops Quality - Quality Systems Ops Lazio

External Site Ops Quality - Quality Systems Ops
Roma
Lazio, Lazio

Pfizer is hiring a Talented, Innovative, Passionate QS&OC/ESOQ Manager for Quality Systems & Operational Compliance team.

QS&OC/ESOQ Manager will report to QS&OC/ESOQ Oncology & Rare Disease Regulatory Operations Team Lead

Geographical scope: Europe

QSOC: Quality Systems Operations Compliance

ESOQ: External Site Operations Quality

Why Patients Need You

The ESOQ - QS&OC Manager will be responsible for regulatory change management activities as a Contractor Regulatory Lead (CRL), management of routine complaints and perform activities in support of lot Disposition decisions (for Biotech only) manufactured by External Supply Operations Quality (ESOQ) managed contractors.

Key Experience Offer of this Role

- Experience in a Pfizer's dedicated and highly effective Quality Assurance organization having quality oversight of Contract Manufacturers.

- Leadership role to facilitate agreements between different teams.

Primary Responsibilities

- Initiate, review and approve regulatory changes through Pfizer enterprise system (i. e PDM) for changes initiated by or impacting ESOQ managed contractors.

- Provide support for the closure of the deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations.

- Main point of contact for Global Chemistry Manufacturing & Controls (GCMC) dpt or Local Regulatory Affairs in Pfizer Country Offices (Single market prods) for the regulatory activities involving the ESOQ contractors.

- As the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similar meeting for ESOQ managed contractors and if needed, participate in Site Quality visits at the contractors.

- Support and Perform Lot Disposition for Biotech semi finished and finished products (if applicable).

What You Offer

Basic qualifications

- Min.

BA/BS in Science, Engineering, Pharmaceutical Sciences or related technical discipline

- Min.

8 years of experience in GXP setting and/or Regulatory Affairs role

- At least 4 years of Product Quality Assurance experience in a GMP environment

- Good command of English language and multi-lingual is a benefit

- Shows strong negotiation skills and is diplomatic in communication with internal and external customers

- Strong verbal and written communication including presentation skills

- Demonstrated personal leadership to manage cross functional project

- Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor

- Able to report remotely and deliver work independently

Preferred Qualifications

- Master's degree and relevant pharmaceutical experience.

- Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener

- Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure

- Supervisory experience desirable

- Up to 10% travel required

- Has a broad GMP and technical know-how to handle emerging issues

- Developing ability to resolve conflicts

Other Job Details

- Contract Type: permanent

- No relocation package available

- Flexible working

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.

Quality Assurance and Control

LI-PFE