Site Quality Operations Lead, Strängnäs

Use your power for purpose

Our science and risk-based quality culture is not only compliant but also flexible, innovative, and customer-oriented. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients.

Your leadership and expertise will drive the strategic direction of your division, fostering a culture of continuous improvement and innovation. Your ability to leverage constructive relationships across divisions will help you maximize the resources available within the organization, ensuring that Pfizer is ready to achieve new milestones and help patients across the globe.

What You Will Achieve

• As a leader in Quality Assurance, you will be working with a team which is responsible for providing leadership in assuring that appropriate systems and processes are in place on site and in business units to meet the requirements of Pfizer and the regulatory authorities for the quality of the products manufactured on site or by approved vendors.
• 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 commercial and clinical manufacture of drug substance and sterile drug products.
• The SQOL partners with site operations 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 QO budget and resource planning, quality performance metrics/quality dashboard, quality strategic planning, quality goals and objectives.
• The SQOL is accountable for staffing, organizing, talent planning, motivation & coaching, effective listening and communication towards his/her QO team.

In this role, you will:

• Assure overall quality integrity of pharmaceutical products manufactured and distributed in worldwide markets based on cGMP regulations and industry standards
• Provide leadership for the quality operations team responsible for release, compliance and laboratory operations
• Assure that all processes, systems, facilities, methodologies utilized in the manufacture and testing of pharmaceuticals or validated and fully integrated
• Establish systems to assure the audit readiness of manufacturing and testing facilities by a regulatory agencies and internal auditors.
• Implement strong communication networks for information flow to and from the plant, senior management, staff teams and regulatory agencies. This includes a robust notification to management process.
• Be an active Member of Site Leadership Team to assure supply, financial commitments and consistently achieve common site goals.
• Foster a culture of continuous improvement and innovation at the site and play e lead role in protecting and strengthening the site quality culture.
• Demonstrate a passion for colleague engagement and be an active change agent.
• Be accountable for staffing, training and development, motivation and coaching, giving feedback and effective listening & communication towards his/her colleagues.
• Respect the PGS vision, mission, values and leadership behaviours in order to realize the PGS objectives.
• Liaise with other SQOLs and Centre functions to ensure aligned direction and response on specific topics.
• Ensure adoption and sharing of best practices across the Pfizer network.
• Keep abreast of evolutions in pharmaceutical production practices, regulatory requirements and company operations affecting all aspects of the pharmaceutical industry.
• Have a reporting line to cluster quality lead and dotted reporting line to the site leader

Education & experience

At least 15 years work experience in the pharmaceutical Industry preferably within different functions within Operations, Quality & Compliance, Validation/Technology with a minimum of 10 years leadership experience, preferably with direct responsibility for a large organization (100+ people).

Ideal candidates will have prior experience and demonstrated success in most, if not all, of the following:

• Making sound and effective decisions under pressure
• Managing a Quality/Operations function with product release responsibilities
• Experience in at least two quality and/or science areas
• Working in functions outside Quality/Operations, e.g. Technology, Validation, Operations, Regulatory  
• Working with other manufacturing and R&D sites to understand a broader perspective
• Exposure to Regulatory inspections including interactions with Board of Health representatives and responding to Board of Health observations
• Working with multicultural, cross-functional work teams
• Advancing a quality culture in a manufacturing environment
• Evaluating and continuously improving site Quality Systems
• Managing managers and teams
• Project management
• Finance planning and budgeting
• Developing and implementing a quality business strategy
• Proficient in Swedish language is preferred

Primarily standard work hours with some exceptions to meet business needs.  Some travel will be required to support network and sister site initiatives.

 
Work Location Assignment: Onsite

Application Closing date: March 8th

Hiring manager Christopher Oakes, International Quality Operations Lead.

Email: [email protected]

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. 

Pfizer Strängnäs is one of Sweden’s largest biotech plant for commercial manufacturing of pharmaceutical active substances with approximately 350 employees. We manufacture five different products where Human Growth Hormone with advanced DNA technique, and a Thrombosis preventive substance are examples of how we helped more than 25 million people around the globe.

Our multi-product facility is a highly effective manufacturing organization with focus on continuous improvements, six sigma and lean. We are fronting several exiting challenges and an opportunity to bring in new technology to optimize our operations.

Equal Employment Opportunity 

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees. 

Disability Inclusion

Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!

Quality Assurance and Control