Director, Global Quality Systems

Leads the Quality Systems organization (based in Cary, IL) and sets the site Quality System strategy. Ensures compliance to FDA and International regulations for pharmaceuticals, devices, cosmetics, and biocides through an effective quality system. Leads the site-wide effort to prepare for and execute regulatory inspections for both commercial and manufacturing organizations. Builds a strong team that works in partnership with the business to drive a collaborative, compliant culture. Facilitates future business growth through effective integration with the Stryker Corporate Quality System and helps build pharmaceutical capabilities locally and within an integrated Stryker distribution network.
Provides leadership for the site?s quality system organization.
Develops, leads, and executes a Quality System Strategy, ensuring that it is appropriate and effective in meeting the business needs and regulatory requirements; including that to support prescription and OTC drugs, medical devices, cosmetics, and biocides.
Develops effective methods for assessing quality system health and drives improvements in collaboration with other functions.
Will interface with external auditing entities and communicate results.
Drives integration activities to meet Stryker Corporate RA/QA requirements, and helps shape the Corporate processes to meet drug requirements Provide senior management with guidance on mandated or industry changes that impact divisional quality system compliance
Responsible for the EU drug importation entity and quality system, ensuring compliance with applicable regulations and shaping the importation strategy for future growth
Establishes and maintains an effective continuous improvement (NC/CAPA) process
Communicates gaps with regulations and standards to senior management.
Provides leadership and participates in all internal and external audit activities.
Participates in corporate development of methods, techniques, and evaluation criteria for projects, programs, and people.
Builds competency across the organization in understanding and applying requirements and best practices of a broad quality system; driving expertise and capability to sustain compliance to drug, device, and cosmetic regulations.
Responsible for the selection, supervision, development and objective setting for teams consisting of managers, individual contributors and clerical/technical staff.
Works with regulatory affairs and quality assurance teams across the Corporation to achieve Stryker?s mission, vision and objectives.
Regularly communicates and drives the overall RA/QA vision, quality goals and achievements to all employees as well as to executive staff on a regular basis.
Supports new business opportunities and acquisitions.
Supports the growth and development of the team as a whole by investing in employee involvement and development by fostering personal growth, being responsible and accountable, being passionate towards the success of the business and treating all with dignity and respect.
Responsible for setting and operating within a budget. Drives the influence of regulations and standards through participation in industry working groups such as AdvaMed and standards committees
Maintains a close partnership with the RAQA organization at Stryker Medical and within the Corporation
+ BA/BS degree in related discipline required. Advanced degree highly preferred.
+ 10+ years of proven leadership experience in a pharmaceutical Quality/Regulatory environment required
+ Must possess excellent communication, strategic thinking, analytical and negotiation skills.
+ Basic skills - Time management, project management, inter-personal, reports and budget, stress management, people management, conflict management, customer service, Windows, advanced computer, statistics, financial systems, ISO13485, FDA regulation, organization structure, and office equipment.
+ Functional skills ? personnel selection, financial systems, organization structure protocol, interdepartmental interface, interdivisional interface and P&L management.
+ Expected to handle complex or difficult situations successfully.
+ Meets cognitive demands to include visual discrimination/memory, auditory discrimination/memory reading ability, independent decision making and retention of specific knowledge.
+ Willing to travel domestically and internationally.
Work From Home: No
Travel Percentage: Up to 25%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer ? M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor?s legal duty to furnish information.
Stryker is one of the world?s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com

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