Quality Assurance Product Lifecycle & Supplier Management - Indianola, PA

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Quality Assurance Product Lifecycle & Supplier Management - Indianola, PA

Quality Assurance Product Lifecycle & Supplier Management – VS3.0 Indianola, PA

JOB DESCRIPTION SUMMARY

Serves as the Qualified Person (QP) as required by governing regulations, ensuring the quality and legitimacy of medicinal products. Responsible for maintaining all necessary processes and procedures for QP certification, overseeing batch release, and ensuring compliance with GMP and regulatory requirements for products manufactured in the country. The QP certifies that each production batch meets the required quality standards and documents this certification appropriately.

PURPOSE

To serve as the VACC (Visionary, Architect, Catalyst and Coach) to the Quality Assurance Product Lifecycle & Supplier Management cluster including QC incoming teams. The incumbent is appointed to set the overall direction and manages all Quality activities related to Suppliers impacting Sterile Disposables and Electro-Mechanical devices built at Indianola, Saxonburg, O’Hara, Heredia, Rydalmere, and External Contract Manufacturing Organizations. This position will work collaboratively with the Sterile/Disposables, Electromechanical Manufacturing, Commercial Organization and Regulatory organizations to provide the necessary technical support and to ensure that quality and compliance strategies are consistent and synergistic with the direction of those organizations and the strategic mission of the Radiology Medical Devices and Bayer overall. The incumbent effectively conducts Quality Management Reviews with executive management, ensure regular monitoring and communicating of established metrics, monitor external standards and assess impact to the business, create and maintain relevant procedures in alignment with internal and external regulations, ensure quality training of personnel, administer an effective CAPA program, conduct internal audit activities and manage external audits and inspections. In this role, the incumbent directs Scientists, Engineers, and Technicians in performing activities to support new product launches and sustaining product supply. In addition to the above, the person in this role sets the direction of the organization through the development and implementation of policies, procedures, and best practices related to Supplier Management.

YOUR TASKS AND RESPONSIBILITIES

• Lead the Medical Device Quality Assurance Product Lifecycle Management cluster to manage and continuously improve the relationship with Radiology / Medical Device suppliers (qualify parts/processes, develop quality agreements, perform QS and process audits, etc). Establish annual quality objectives and metrics to support the priorities of the business;

• Establish strategies to lead the Medical Device Quality Assurance Product Lifecycle Management cluster ensuring the appropriate Supplier quality systems and disciplines are in place to support the Radiology business; ensure alignment with the Bayer Quality Management System. Actively participate in global Quality System initiatives driving appropriate inclusion of Medical Devices where appropriate;

• Support the Radiology Quality Committee to manage and continuously improve the global Radiology Quality Management System. Establish annual quality objectives and metrics to support the priorities of the business. Actively support R&D (New Product Development) and plant operations to establish state of the art part quality and resolve quality issues with parts;

• Assure global compliance to worldwide standards and regulations – FDA Quality System Regulation (Part 820), ISO 13485, European Medical Device Directive (MDD), Canadian Medical Device Regulation, Medical Device Single Auditing Program (MDSAP), Japan, ANVISA and other country specific regulations. Actively qualify and interact with suppliers according to risk-based approaches to ensure optimized interaction with Site Quality;

• Ensure a system is in place to stay abreast of changes in standards and regulations, assess the impact to Radiology processes and adjust the QMS accordingly;

• Monitor the QMS through a set of common, concise, and meaningful Supplier quality metrics that support the business. Provide trending of the metrics and communicate to Executive and Senior Managements on a regular basis;

• Conduct periodic Quality Management Reviews of supply base performance with Site and Executive Management;

• Establish well written and structured Supplier Quality QMS procedures to comply with external standards and regulations. Ensure procedures are updated to reflect changes in standards and regulations. Align Radiology procedures with Bayer procedures. Closely interact with Enabling Quality;

• Assure an effective system of audits including tracking of audits findings to closure. Facilitate the use of auditors across the organization to drive a culture of quality within various disciplines;

• Maintain an effective system for supplier corrective actions used to document quality issues as well as the actions taken to effectively resolve these issues. Ensure cross-functional individuals are engaged in reviewing and supporting the effective implementation of these continuous improvements;

• Support a learning management system to ensure QMS training is effectively created and implemented for Radiology employees. Drive an "audit ready everyday" approach with the organization;

• Support external audits / inspections conducted by FDA, BSI, etc. Lead all aspects of those inspections related to Supplier Quality;

• Develop and lead staff with a focus on enhancing personal development to support career aspirations. Provide coaching and feedback to maximize staff performance. Acquire feedback from internal customers to feedback continuous improvement;

• Actively engage in industry quality organizations to stay abreast of industry changes, best practices and bench marketing to support continuous improvement opportunities;

• Inspire a culture of quality across all disciplines to drive value for our customers beyond compliance;

• Ensures the sites are prepared for and successfully manage external regulatory inspections in all aspects related to Supplier Management;

• Maintains awareness of current ISO/GMP trends, regulatory agency, and Notified Body expectations in the industry with respect to Supplier Management practices;

• Incumbent demonstrates, credibly embodies and showcases VACC leadership being a:

• Visionary who guides teams in defining the outcomes to deliver on the mission;

• Architect who shapes a value creating system to unleash the passion and energy of our people;

• Catalyst who removes roadblocks to facilitate connections and collaboration;

• Coach who helps teams learn and build the capabilities needed to create value for the customer and stakeholders.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

REQUIRED QUALIFICATIONS

• MS in Engineering or the life sciences or an MBA plus a BS in Engineering or the life sciences. The minimum requirement for the role is a BS in Engineering or the life sciences.12-15 years Scientific and/or Engineering Functional Management, Project Management, or Operations Management Experience. The position requires at least 10 years of experience within a manufacturing environment, preferably Engineering, Quality Assurance and/or Project Management;

• Individuals must possess at least five years of functional/team leadership;

• Must possess or gain by study a thorough familiarity with Quality System requirements: FDA’s Quality System Regulation, ISO 13485, European Medical Device Directive (MDD), Canadian Medical Device Regulation, Japan Pharmaceutical Affairs Law and other pertinent country regulations;

• Direct experience with implementation and continuous improvement of the quality system;

• The role requires a knack for analytical skills; strong managerial courage; a bias towards making decisions; and a solid understanding of a wide range of quality improvement tools;

• The ability to recognize and manage risk in a methodical manner is also of critical importance to this role;

• Requires strong organization, communication, leadership, and management skills to direct diverse, multi-disciplinary functions; prepare and manage budgets; and select, develop, and motivate a qualified staff;

• Individuals must be highly capable at adapting to change; dealing with ambiguity; and make decisions in a high pace manufacturing environment;

• Strong partnering / stakeholder management skills across different business, functions and locations;

• Excellent team player, change management experience and capabilities;

• Proven experience in international and cross-functional leadership roles;

• Applies VACC leadership behaviors and approach;

• Demonstrates high self-awareness as well as system awareness;

• Pro-actively asks for and gives feedback;

• Demonstrates strategic thinking as well as good business- and external trends insights;

• Focuses on outcomes: defines and delivers highest pipeline-, team-, talent- and organizational-impact-outcomes;

• Collaborates with accountability: collaborates and holds each other accountable in and across teams;

• Co-creates for customers: is close to the customer and co-creates solutions for their needs;

• Acts, learns fast and evolves: works in 90-days cycles, applies learnings fast and continually develops;

• Creates impact by realizing authentic self and purpose, and includes others: respects differences, embraces inclusion and shows up as the best self;

• Dynamically allocates talents with right skill set to customer-, product- and design-teams, based on business needs and defined outcomes.

Employees can expect to be paid a salary between $177,600.00 to $266,400.00. Additional compensation may include a bonus or incentive compensation (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc..

This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

This posting will be available for application until at least 7-6-2026.

YOUR APPLICATION

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Health for all, Hunger for none, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.

To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Equal Opportunity Employer Statement: Notice for U.S. Visitors: All information on this site is subject to compliance with local rule and regulations as they may vary from time to time and across different geographies, including, without limitation, U.S. Executive Orders.

Bayer is an E-Verify Employer.

Location: United States : Pennsylvania : Indianola

Division: Pharmaceuticals

Reference Code: 871386

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