Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Collegeville

Description

ROLE SUMMARY
The Director/Regional Team Leader Supply Chain & Market  Quality Operations (SCMQO) oversees the   organization and is responsible for the following:
•    Overseeing GMP/GDP and Quality Operations at in the markets of responsibility 
•    Developing, implementing and continuously improving quality systems that assure compliance with Pfizer and  regulatory requirements, enhance quality and mitigate risks.
•    Providing leadership, direction and development to SCQ colleagues in the region.
•    Engaging with Country Management and Regional and Country Medical and Regional Affairs groups to ensure alignment and support for within market quality and compliance activities.
•    Faciliate development and execution of objectives consistent with SCMQO objectives and  strategies.
•    Tracking quality metrics and implementing actions to continuously improve performance. 
•    Sponsor SCMQO global projects and support  global teams to deliver on time and on quality.
•    Represent SCMQO on PGS, QO and PFE initiatives and teams as appropriate.


ROLE RESPONSIBILITIES 
Specific responsibilities include but are not limited to:
•    Establishing and continuously improving the quality systems at the  country offices  covering complaint handling, notification to management, investigation of quality deviations, execution of market action decisions, management of logistics service providers, evaluation and release of cold chain products, local relabeling and repackaging etc. 
•    Evaluating compliance with applicable GMP/GDP requirements and implementing continuous improvement plans as needed. 
•    Supporting the investigation of, and implementation of corrective/preventive actions for, quality issues arising within the markets. Notify management of significant issues. 
•    Work collaboratively with other functions and groups including GSC to enable product supply 
•    Support business growth and development in the respective markets.
•    Supporting preparations for AQRT meetings and implementation of market actions and/or regulatory communication actions
•    Liaising with regional and country Business Unit Leadership to ensure appropriate resources are in place to achieve compliance with quality system requirements. 
•    Supporting the recruitment, training and development of SCMQO colleagues.
•    Supporting the development  and execution of SCMQO objectives. 
•    Providing updates to management on PCO quality performance and continuous improvement initiatives. 
•    Instilling a culture of quality,  compliance and continuous improvement at Affiliates
Enhancing contributions to the PGS value proposition by thinking and acting as a strategic business partner.


QUALIFICATIONS 
Indicate qualifications that are job related, consistent with business necessity and necessary for the performance of an essential function of this role including: education/licenses/certifications, relevant experience (where legally permissible), technical and/or other job-related skills.
•    At least Bachelor’s degree in Pharmacy or related science
•    Minimum 10 years experience in the pharmaceutical industry, preferably in Quality Operations
•    Minimum 5 years of demonstrated success leading and developing professional colleagues
•    Record of successful interactions with regulatory agencies and internal and external stakeholders. 
•    Broad, current knowledge of EU GMP, GDP and regulatory requirments related to quality matters, such as drug shortage reporting, Falsified Medicines
•    Proven leadership skills and demonstrated ability to drive organizational change and continuous improvement.
•    Experience working in complex organizations, with demonstrated excellence in developing and managing effective teams and working across multiple cultures.
•    Demonstrated experience in quality decision making and problem solving in a complex environment
•    Strong technical writing and presentation skills
•    Demonstrated ability to influence and drive actions in areas outside direct control
•    Fluent in English , both written and spoken, is essential.


 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS 
Primarily office work .  About 15  % travel


ORGANIZATIONAL RELATIONSHIPS
Primary interactions with Global Quality Operations, PGS sites, Regional and Country Business Unit Management, Regulatory Affairs,  as well as local and regional regulatory agencies.


RESOURCES MANAGED
Financial Accountability
N/A

Supervision
The regional organization is planned with about  20 colleagues with 8 direct reports to the position. The countries are …… 


 


Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

About the company

Pfizer, is an American multinational pharmaceutical corporation headquartered in New York City, New York, with its research headquarters in Groton, Connecticut. It is among the world's largest pharmaceutical companies by revenues.

Pfizer develops and produces medicines and vaccines for a wide range of medical disciplines, including immunology, oncology, cardiology, diabetology/endocrinology, and neurology. Pfizer's products include the blockbuster drug Lipitor (atorvastatin), used to lower LDL blood cholesterol; Lyrica (pregabalin for neuropathic pain/fibromyalgia); Diflucan (fluconazole), an oral antifungal medication; Zithromax (azithromycin), an antibiotic; Viagra (sildenafil, for erectile dysfunction); and Celebrex/Celebra (celecoxib), an anti-inflammatory drug.

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