Responsible for implementing, and maintaining the quality system including the quality policy, the quality plan, and the organizational structure to support the quality system.
Works with suppliers and internal stakeholders to ensure products continue to be safe and effective. Manages supplier and Third-Party Manufacturer (TPM) inputs and outputs eg. change notifications, non-conformities, CAPA’s, quality agreements, projects. Ensures Global Supply Chain Quality Assurance (GSCQA) area is aligned with the long-term business strategy.
Functions well within a matrix organization. Uses metrics to measure performance. Recognizes risk relative to product issues and takes appropriate actions while maintaining compliance to processes and procedures including use of Risk Management tools. Has excellent problem solving skills and makes timely decisions while considering the facts and data at hand.
Possesses strong communication skills and is able to adjust style to respective audience (managers, peers, customers, executives, etc.). Makes decisions: Utilizes good judgment and makes timely decisions which consider the facts and data at hand. Knows when to escalate to management and presents possible resolutions. Takes personal responsibility to resolve issues.
Plans for Development of Direct Reports: Assesses strengths and development needs of direct reports and provides feedback; gives input into development plans; provides opportunities for growth and learning.
Develops Organizational Talent: Develops succession plans for key positions within organization; and creates development plans to prepare potential successors for increased responsibility.; Plans Activity Structure: Makes plans to accomplish assigned activities and projects; establishes priorities so as to handle competing demands; optimizes use of available resources; estimates time and resources necessary to complete tasks or projects. Provides input to resource requirements.; Creates a Motivational Environment: Promotes productivity and morale by treating others with respect and dignity; listening to different points of view; taking ownership and responsibility for own actions; modeling the behavior expected of others; following through on commitments; being available to answer questions; providing positive feedback on individual and team accomplishments; and providing developmental feedback in a timely and non-defensive manner.
Confronts Issues: Raises issues that block the achievement of individual and team performance; voices opinions and concerns without waiting to be asked; and attempts to establish areas of difference as well as areas of common interest. Actively promotes conflict resolution.
Influences Outcomes: Influences others to support a course of action and to incorporate quality concepts in all activities; appropriately uses authority; influences activities without reliance on formal authority; and communicates unpopular decisions in a realistic but favorable light.
Position Accountability / Scope:
Manage a team providing support to product line(s) and/or functions. Accountable for compliance to site and division procedures. Ensures that quality and compliance requirements are communicated and implemented. Sign off at team level within delegated parameters; first level approval for change control; may have second level approval authority. Project and activity horizon is typically 1-3 years. Accountable for budget and financial results and timeline achievement. Develop the budget; analyze and prioritize needs. Spending authority is limited; proposals for additional funds are closely reviewed. Influence and visibility on supported projects and activities may extend to larger organizational units; customers and professional organizations.
Bachelor's Degree preferred in a technical/scientific discipline or closely related field. Equivalent work experience in a similar position may be substituted for minimum educational requirements.
Minimum Experience / Training Required:
6 - 10 years’ experience preferably in a quality/ technical/engineering area. Demonstrated leadership experience through formal and/or informal assignments is preferred. Knowledge of regulations and standards affecting IVDs and Biologics. Background in process engineering and/or quality engineering would be a distinct advantage.