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Site Quality Operations Leader (m/f/d) in Freiburg, Germany Freiburg im Breisgau

Pfizer Pharma GmbH

Pfizer Pharma GmbH Freiburg im Breisgau Germany

1 month ago

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.

What you offer:

EDUCATION & EXPERIENCE
• Extensive experience in manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA (or higher) Degree in Science/Engineering.
• Preferred 5 or more years of Quality Operations experience and familiarity with Drug Product manufacturing.
• People Leadership (leader of leaders) and talent development experience.
• In-depth knowledge and experience of pharmaceutical cGMP, principles and concepts of relevant quality processes based on previous roles.
• Ability to function autonomously in a matrix model and in a team environment.
• Able to communicate complex information and analyses to a variety of scientific and non-scientific audiences in both verbal and written formats.
• Excellent interpersonal and leadership skills including a demonstrated ability to positively influence and coach others.
• Experience influencing Board of Health inspections and successful interactions with inspectors.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
• Must be fluent in German and English
• Preference for candidate to be eligible to act as EU Qualified Person according to § 15 AMG and in accordance with EU requirements 2001/83/EC Pharmaceutical and EU GMP, Annex 16.
• Some travel will be required to support network and sister site initiatives; ~10% required travel.
• Work Location Assignment: On Premise at Pfizer Manufacturing Deutschland GmbH, Freiburg plant. Up to 40% remote working allowed, subject to agreement with GSM Quality Cluster Lead.

Together we stand for:

Breakthroughs that change patients' lives - In order to fulfill our corporate purpose, a value-oriented corporate culture guides our actions. Pfizer's values are: Courage, Excellence, Equity & Joy.

Courage: One bold way we are achieving our goals is our company-wide digital transformation strategy. Our flat hierarchies enable short decision-making paths.

Excellence: We focus on what is really important, take responsibility, measure progress and work together in a spirit of trust. Together we rely on an agile way of working that encourages our employees to balance their private and work lives and to promote personal development.

Equity: We believe that different experiences are valuable, which is why every opinion is heard and valued. These experiences and opinions enrich the entire company. In this way, we promote a diverse and inclusive working environment in which colleagues in various Diversity, Equity & Inclusion (DE&I) working groups such as, e.g. Engage Empowered Women, LGBT*IQ , DisAbility, X-Gen.

Joy: If we experience our work as meaningful, we get a lot in return. We achieve this by being proud of the contribution we make, appreciating each other and sharing this with joy and recognition. Our BRAVO Award program gives us an appreciative opportunity to do so. Our employees benefit from a comprehensive company health management "Pfizer in Balance" also during working hours.

Discover your way. Apply today.

Kontakt
Freiburg im Breisgau Germany

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