Quality Technical Operations Utilities, Facilities, Process Technologist

Use Your Power for Purpose

Reporting to the Senior Director Internal Manufacturing Operations Quality (Sterile Injectable & Biotech Quality Technical Ops Lead), the role works with Global Technology, Engineering & Launch (GTEL), Pharm Sci and all Pfizer Global Supply sites as required, providing key support for SI/Bio related site quality technical operations activities and facility design. The role will include strategic and tactical leadership of cross-disciplinary teams to enable effective quality and compliance outcomes related to commissioning, qualification & verification of new facilities and facility/utility changes, remediation activities and implementation of new technologies.

It will involve directing and coaching sites on standardized approaches to specific quality requirements for new facilities, facility changes and upgrades & system activities. The role will work on issue resolution & initiatives pertaining to achieving effective quality and compliance outcomes related to commissioning, qualification & verification, risk assessments, control strategy development, remediation activities and new technologies & manufacturing innovations. This position will work closely across the respective Site Leadership Teams, as well as liaising closely with the Operating Unit Quality Operations Leads and other center Quality colleagues as well the GTEL Technical & Engineering teams, Regulatory, R&D and Drug Safety functions.

What You Will Achieve

The position is responsible for the following activities as assigned including (but not limited to):

• Support and leadership of SI/Bio platform to ensure consistent quality approaches for commissioning, qualification & verification of new facilities and facility changes and manufacturing processes e.g. Utility and Facility requirements and design in a regulated environment, manufacturing processes, aseptic requirements, standardized approaches, Next Gen innovations, lab of the future & predictive plants.
• Partner with GTEL Process and Engineering Technology teams.
• Collaborating closely with Operating Unit and Operating Unit Quality Leaders to review metrics, provide guidance on Utilities and Facility Quality requirements, identify necessary enhancements and initiatives, support new product launches and tech transfers.
• Leadership / Approval of Complex initiative and facility designs and Quality oversight to guide and control strategy development.
• Develop site colleagues in their understanding of policies and procedures and associated requirements and provide advice and facility/Utility guidance at site level.
• Provide subject matter expertise to drive simplified/standardized global and local processes for key technical disciplines.

Here Is What You Need (Minimum Requirements)

• Bachelor’s degree with at least 6+ years of experience; OR a Master’s degree with more than 5+ years of experience; OR a Ph.D. with 1+ years of experience.
• Experience in Pharmaceutical manufacturing Facility role, technical or quality roles in a related discipline.
• Strong knowledge of quality and compliance requirements, commissioning, qualification & verification.
• Proven leadership skills and ability to achieve results through others.
• Proficient in computer skills. (e.g., Microsoft Office, ERP systems, MS Project).

PREFERRED QUALIFICATIONS

• Relevant pharmaceutical experience. 
• Experience working with complex organizations.  
• Experience with Operational Excellence techniques (six sigma, etc.)
• Excellent interpersonal skills including a demonstrated ability to influence and participate in teams at all levels of management.
• Ability to drive change and positively influence others.
• Leadership, integrity, team orientation, flexibility, creativity, experience in projects that require collaborative approaches, strong analytical skills and a solid ability to understand business issues and processes.
• Very strong communication and coaching skills.
• Experience of incident management processes through NTM, ESQRT, AQRT and BoH notification.

PHYSICAL/MENTAL REQUIREMENTS

• Takes appropriate risks to achieve desired results; guides direct reports on acceptable levels of risk-taking​
• Uses knowledge of industry, customer requirements and general business environment to adapt and implement strategic actions for the Global Business Unit/Global Operating Unit or Sub Business Unit/Sub Operating Unit​
• Leverages a variety of communication tools and techniques to help colleagues understand how their work aligns to business priorities
• Contributes to an open communication environment to ensure the k