Quality Assurance & Compliance Manager

Created by: Pfizer
Added: 16.10.2019

Advert description

The Site Quality Assurance Senior Manager will enable Quality Excellence at the Toluca site; ensuring a strong Quality, compliance and performance culture for site Quality Assurance and Regulatory teams. The role is accountable for the release of quality products from the site, ensuring regulatory compliance with all market authorizations, quality systems and process (which encompasses materials, packaging components, in process and commercial products).

The Site Quality Assurance Senior Manager is responsible for providing leadership in assuring that appropriate Quality systems and processes are in place to meet or exceed the requirements of Pfizer and the regulatory authorities for the quality of the products manufactured on site.

Key focus areas and responsibilities for this position include: Overseeing Quality Assurance and Regulatory functions and leading Site Quality Review Team (SQRT); optimizing all elements of quality operations, in particular delivering on continuous improvement initiatives in QA and regulatory compliance; planning, implementing and achieving site Quality objectives consistent with Site Objectives; providing leadership, development and direction to the Quality team; interfacing with global regulatory agencies.

The Site Quality Assurance Senior Manager will lead, manage, develop and sustain a diverse team of talented and engaged technical professionals with the responsibility of providing comprehensive support, leadership and guidance to all operations at the site in assuring that appropriate systems and processes are in place at Toluca site, to meet or exceed the requirements of Pfizer Quality Standards and applicable cGMP regulations.

The scope of this role also includes quality budget and resource planning, quality performance metrics monitoring, adherence to Leaders Standard Work, quality specific projects management, planning, implementing and achieving Site Quality Assurance Senior Manager Objectives.

This position will report to the Toluca Site Quality Operations Leader.

Manage overall quality assurance and compliance disposition of pharmaceutical products manufactured and released at the plant and by approved contract manufacturers, based on GMP regulations and Pfizer Quality Standards (PQS’s);

Provide leadership, development and direction to the Quality Assurance and Regulatory teams; Develop and maintain an organizational structure consistent with the area needs and goals, including the preparation and administration of annual performance assessments and one-to-one discussions;

Assure the implementation, maintenance and improvement of a robust quality system to identify and resolve GMP issues;

Manage site compliance to PQSs and implement appropriate actions;

Plan, implement and achieve Site Quality Assurance and Regulatory objectives, consistent with Site objectives.

Engage colleagues in achieving and exceeding the site and area objectives;

Develop the annual budget for the department, such as direct expenses and staffing budgets with continued assurance of cost improvement;

Manage the financial performance of the department and support Continuous Improvement Projects (CIPs) to ensure goals are achieved or exceeded;

Approve quality and laboratory investigations reports for deviations (QARs and LIRs);

Review and approve key quality, compliance and regulatory documentation and implement appropriate actions;

Lead and engage the Site Quality Review Team (SQRT).

Provides support for key quality issues in preparation for AQRT's process.

Assure that all processes, systems facilities, methodologies utilized in the manufacture/ testing of products are qualified or validated;

Establish systems to assure the inspection readiness for manufacturing / testing operations by regulatory agencies;

Evaluate site quality and cGMP compliance risk, communicate risk and implement mitigation plans to reduce the risk to Pfizer and to Pfizer's customers.

Coordinate development of area training plans in order to manage the training, qualifications and educational needs of the Quality colleagues;

Interact with regulatory agencies to bring science based and innovative approaches to subjects under review;

Engage in the local and external quality and regulatory communities.

Support manufacturing and analytical product transfers associated with the sites.

Support hiring/development of colleagues for key site Quality positions.

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

Specific details

Type of Contract Full time
Preferred Education Bachelor's
Level of Experience 2-5 years

Location

Mexico, North America
Toluca