Senior QA Manager

The incumbent will be required to develop strategic and system action plans by conducting risk assessment, identifying critical control points and preventive measures, establishing critical limits, monitoring procedures, corrective actions, and verification procedures. The incumbent will ensure that the quality systems, the products manufactured and Good Manufacturing Practice (GMP) related operations observe consistent compliance with cGMP, Pfizer Quality Standard (PQS) policies, site Standard Operating Procedures (SOPs) and regulatory guidance. The Incumbent will work across all site functions to accomplish site-wide QA manufacturing operations objectives. The incumbent will have an excellent knowledge of cGMP, cGLP, cGAMP and knowledge of active pharmaceutical ingredient (API) manufacturing. The incumbent will interact with all departments on site and will need to be a self-starter with good interpersonal skills and excellent written and oral communication skills the incumbent will lead a team of QA professionals and will need to be action-orientated and a strong leader for the quality culture of the site.

**Responsibilities**:

- Lead, direct and develop the Quality Assurance Team.
- Lead, direct the QA validation team and provide guidance on planning and execution of validation projects
- Develop and communicate appropriate objectives, priorities and metrics for the team.
- Instigate a culture of lean operations by reviewing existing work practices and reducing non-value added activities in a systematic manner.
- Ensure all manufacturing and operations remain in full compliance with Regulatory filings and submissions.
- Ensure the appropriate systems are in place such that the site operations meet or exceed the requirements of the company and the regulatory authorities for the quality of the products manufactured on site: responsible for batch disposition.
- Review and approve quality operations and manufacturing quality assurance reports and investigations for deviations from approved manufacturing processes or specifications when and where required.
- Enhance site technical staff’s knowledge of current Good Manufacturing Practice (cGMP); current regulatory requirements; Good Automated Manufacturing Practice (cGAMP) and general validation principles.
- Review and approve quality operations and manufacturing quality assurance reports and investigations for deviations from approved manufacturing processes or specifications when and where required.
- Coordinate, develop and track Quality Operations metrics.
- Support, promote and demonstrate corporate and Pfizer Global Supply (PGS) vision, values, and leader behaviors.
- Allocate department staffing and manage the utilization of facilities and equipment to ensure that departmental objectives are met.
- Conduct performance assessment and development reviews of staff as part of the department development efforts.
- In times of absence of other Quality Assurance Managers and, as directed by the Quality Operations Director from time to time, take up the responsibilities to cover other Quality Assurance Manager roles.

Job Related Requirements:

- Demonstrated record of successful interaction with global regulatory agencies (e.g. FDA, HSA, MHRA) and other internal and external auditing groups.
- Successful track record of continuous improvement, development, and/or implementation of best practices in quality operations or manufacturing.
- Thorough knowledge and understanding cGMP, GAMP, validation principles, and applicable regulations related to validation principles.
- Thorough knowledge and understanding of the technical and commercial aspects of pharmaceutical API products.
- Excellent verbal, written and interpersonal communication skills.
- Demonstrated ability to interact effectively with senior management, auditors and regulators.
- Supervision_

The incumbent is responsible for 10-13 direct reports.

EXPERIENCE
- Minimum 8 years of directly related experience in pharmaceutical manufacturing and quality operations, or equivalent combination of work experience and education.
- Related experience should be in GMP-regulated industries in Manufacturing Operations, Process Validation with Quality Systems knowledge such as Change Control, Deviation and CAPA.
- Must have a working knowledge of FDA and ex-USA regulatory requirements as well as pharmaceutical industry quality systems.
- Must have an understanding of pharmaceutical industry trends and practices.
- Minimum 5 years in a supervisory capacity.
- Experience in an API manufacturing plant is preferred.

Work Location Assignment: Flexible

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

Quality Assurance and Control

LI-PFE