Manager – Logistics Quality Operations

JOB FOCUS

The Manager, Logistics Quality Operations is accountable for providing quality assurance management of key logistics contractors for Pfizer and for assuring that the products stored at the Logistics Service Provider premises are stored in accordance with Pfizer and Industry Good Distribution Practices, product registration file and country specific requirements.

The Manager, Logistics Quality Operations provides the Quality Authority and accountability (Quality decision, negotiation and spokesperson) on behalf of Pfizer to those designated outsourced Logistics Service Providers.

The Manager, Logistics Quality Operations will operate in close collaboration with the Logistics Service Provider quality organisation, attend and represent Pfizer at Logistics Service Provider quality meetings as well as Business Review Board meetings, supporting complex change and improvement projects, data trending, digital process integration and resolution of complex failure modes and events.

This is highly independent position operating with minimal supervision, interacting with high levels of management both at Logistics Service Provider and within Pfizer.

The Manager, Logistics Quality Operations will have significant interactions with many internal business, manufacturing as distribution organizations (e.g. SC&ESQ, PGS site, Intercompany Operations, External Supply etc.).

JOB SUMMARY - MAIN AREA’S OF RESPONSIBILITY / ACCOUNTABILITIES

Logistics Service Provider Quality oversight

Activities include but are not limited to the following:

• Works collaboratively with Pfizer Global Supply (PGS), Project Teams and External Supply Quality (ESQ) to support qualification and on-boarding activities of Logistics Service Provider.
• Leads and conducts Quality due diligence assessments of Logistics Service Provider in support of Business initiatives.
• Partners with Project Teams to support new initiatives and new product launches ensuring readiness of both contractor(s) and product(s).
• Lead the development, implementation and support of QA/QC systems for Logistics Service Provider.
• Negotiates Quality Agreements.
• Provide Quality Leadership of assigned Logistics Service Provider (s) within the Intercompany Organisation logistics network.
• Support the individual and holistic needs (Technical, communication and regulatory needs) of the Quality Operations and compliance team members for Intercompany Operations.
• Drive the development, implementation and continuous improvement of Quality Systems to support Pfizer, regulatory and industry requirements.
• Proactively support regulatory inspections at Pfizer country office, Intercompany Operations Quality and Logistics Service Provider supporting distribution of Pfizer’s products. Ensure appropriate Pfizer review/approval of responses to Regulatory Agencies including tracking of CAPA’s within QTS (if required).
• Provide Quality Leadership for significant deviations at Logistics Service Provider that may impact compliance status or require regulatory notifications.
• Ensure implementation of effective CAPA and quality system improvements based upon determined remediation activities.
• Prepare ad-hoc SQRT, routine SQRT and AQRT summaries and participate in relevant meetings. Prepare, review and/or issue Ntms as required.
• Lead quality risk management activities and manage mitigation plans within Logistics Service Provider.
• Accountable for the on-time disposition of products with the Logistics Service Provider, supporting the Intercompany Operations Quality team in line with agreed schedule.
• Provide Quality leadership for customer complaint investigations associated with logistics operations.
• Prepare for and revision of metrics.
• Represent Intercompany Operations Quality at Logistics Service Provider quality meetings as well as Business Review Board meetings.

Frequent travel is expected (within the country).

QUALIFICATIONS:

• Level of Education
  • Minimally BA/BS Science, Engineering or related technical discipline
• Experience
  • At least strong working experience in a GxP setting
  • Experience with GDP mandatory
  • Experience with external suppliers/contractors is preferred.
• Languages
  • Strong written and spoken command of English language is required as a core requirement, with knowledge of both French and Dutch knowledge desired
• Computer skills
  • Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, Documentum platforms

Competencies:

• Knowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA, FAGG, HPRA and WHO) is a requirement.
• Ability to communicate effectively verbally and in writing, good negotiation and influencing skills.
• Insight and understanding of shareholders needs and requirements.
• Dynamic, flexible, enthusiastic and eager to learn.
• Takes initiative and ownership to deliver on time without compromising on quality.
• Ability to work under minimal supervision and in a team.
• Able to demonstrate good planning and organization skills.
• Ability to apply technical knowledge and understanding to making appropriate and timely risk-based decisions.
• High level of self- integrity and ethical conduct

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.

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