A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Right now, we are seeking highly qualified candidate to fill the position Site Quality Operations Leader (m/f/d) at the PGS site in Freiburg, Germany.
Position Summary
Pfizer Manufacturing Deutschland GmbH, Freiburg is a key solid oral dose manufacturing site in the Pfizer Global Solids Manufacturing (GSM) network.
The Site Quality Operations Leader (SQOL) is responsible for the operational and strategic management of a diverse range of quality control, quality assurance and quality system operations to support Clinical and Commercial manufacture of small molecule Solid Oral Dose products for global markets.
The SQOL partners with Site Operations, other Pfizer Sites, Co-Development, Analytical Research and Development and other stakeholders to drive regulatory excellence, ensures a supply of quality products from the site which are compliant with regulatory requirements to meet customer needs.
The SQOL is accountable for the product quality, regulatory compliance, quality systems, and processes for the site. The scope of this role also includes quality budget and resources planning, quality performance metrics/quality dashboard, quality strategic planning, quality goals and objectives, and quality specific projects.
The SQOL is accountable for providing leadership to the site in establishing compliance with marketing authorizations of all materials, packaging components, in-process and final commercial products with established specifications, compliance with all relevant German and global regulations and other applicable standards.
This position will have a dual reporting relationship to the Freiburg Site Leader and the GSM Cluster Lead and will be a member of both the Freiburg Site Leadership Team (SLT) and the GSM Quality Leadership Team.
All areas and functions of the Quality Operations department report to the job owner as follows:
- Department Lead Quality Assurance and Reg Compliance
- Department Lead Laboratories
- Sr. Team Lead Quality Analytical Services (QAS)
- Quality Lead High Containment Facility
- QO Business Analyst
- Head of PPD Analytical Services in respect of release of IMPs
Position Responsibilities
Relationships: Achieves compliance and business results through Partnerships between Quality and Operations and other site/cross site functions e.g PharmSci, Regulatory, Co-Development teams, etc. Is an active member of the Site Leadership Team.
High Performance Culture: Creates a high achieving Quality Operations team with goals and values aligned with other team members and operations, collaborative team environment, and high-performance culture within the site Quality Operations organization.
Operational Excellence: Drives innovation and continuous improvement through Operational Excellence (OE) in all QO activities and supports OE throughout the site. Promote a simplification mindset across the site quality organisation, revolutionising the approach to quality work.
Talent Management Focus: Oversees the conduct of Talent Management programs to develop future Pfizer leaders and the creation of robust succession plans for the Site Quality Operations Organization. Directs, oversees and participates in the recruitment, selection, promotion, termination and performance management of site personnel in leadership and critical roles.
Safety: Ensures that all QO operations are performed in a safe environment in accordance with all applicable EHS policies and procedures.
Issue Resolution: Ensures the creation and implementation of clear and timely action plans for issue resolution with appropriate escalation, communication, and closure.
Regulatory Excellence: Ensures sustainable regulatory excellence through systems, science, people, and continuous process improvements. Ensures a favourable site regulatory profile through constant inspection readiness programs; ensures successful Board of Health inspections. Creates effective relationships with BOH to create trust and credibility. Prepares the site for changes to regulations.