Sr Manager, Compliance

Abbott Rapid Diagnostics is part of Abbottâs Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The position of Senior Manager, Quality Assurance within our CMI business unit in San Diego, CA. 

WHAT YOUâLL DO

In this role you will manages subordinate QA management and or experienced QA specialist employees who exercise significant latitude and independence. Often heads one or more teams. Establish operating policies and procedures that affect departments and subordinate sections and work units. Interprets companywide policies and procedures. Develop budgets, schedules and performance standards. Assignments are objective oriented. Work is reviewed in terms of meeting the organization's objectives and timelines.

RESPONSIBILITIES:

• Provide direction and leadership for product quality and compliance.
• Interacts frequently with internal and external management and senior-level representatives concerning projects, operational decisions, scheduling requirements and or contractual clarifications.
• Leads briefings and technical meetings for internal and external representatives.
• Responsible for managing multiple quality system elements/functions as defined in the site Quality Manual.
• Decision making that has an extended impact on work processes and outcomes, that could cause substantial expenditure of additional time, human resources, and funds; and jeopardize future business activity.
• Develop, implement and improve quality processes and procedures, automated systems and reporting systems.
• Implements the quality plan in accordance with the quality objectives/goals and maintains the effectiveness of the quality system.
• Serves as representative for external regulatory inspections and audits.
• Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
• Responsible for ensuring that functional areas of responsibility have adequate training programs for adhering to all safety requirements and business EHS goals.
• Develop quality goals based on the business strategies, collaborates with other business units on common goals and drives for results.
• Leads complex process improvement teams and/or initiatives.
• Establishes and implements necessary communication strategy for the improvement and awareness of the quality issues.
• Responsible for the development and management of staff.
• Ensures that product acceptance activities are handles in a manner that complies with all pertinent regulatory requirements. Reports on the performance of the quality system.
• May be responsible for global QA function within one discipline or multiple disciplines at one site.
• Balance complex resource needs across QA functions.
• Responsible for department financials and for managing cost improvements.
• Identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
• Define and implement superior Process Control & Monitoring systems for KPIV and KPOV throughout the product lines â Critical Parameter Management.
• Oversee the Nonconformance and Real-time data management portions of the Quality System.
• Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and proactive improvements.
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Assures that the Quality continuous improvement processes (NCâs and CAPAâs) meets ARDx metric expectations for key metrics and assure that when metrics are not achieved that clear plans for improvements are implemented and achieved.
• Will be a part of the team that interfaces with external audits and may serve as the subject matter expert  frequently communicating with external legal or regulatory bodies.
• Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.
• Translates department goals into individual objectives and KRAs.
• Monitors daily work operations and provides direction and guidance to, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.
• Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
• Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.
• Provides manufacturing support by defining work assignments directed to address manufacturing process defects and implement process improvements utilizing Quality System tools.
• Monitors departmental activities and records to ensure compliance independent action through critical decision making.
• Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.
• Manages performance of staff towards department and Company goals, including feedback on performance, appraisals, recommendations for merit increases or necessary disciplinary actions, communication to employees on performance, etc.
• Demonstrates commitment to the development, implementation and effectiveness of Abbott Quality Management System per ISO, FDA, and other regulatory agencies.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the companyâs policies and practices; build productive internal/external working relationships.
• Carries out duties in compliance with established business policies.
• Other duties as assigned, according to the changing needs of the business.

EDUCATION AND EXPERIENCE YOUâLL BRING

Required

• BS/BA degree in a science related or technical field or equivalent combination of education and work experience.
• Minimum 10 years progressively work experience in medical device or high technology industries.  Roles of increasing responsibility, impact, and scope within a manufacturing support environment in quality desired. 
• Minimum of seven years related experience working in a professional environment where compliance was of vital importance and management experience.
• Minimum 6 yearsâ of direct supervisor experience.
• Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostic.
• Knowledge of Quality System Regulations and/or ISO 13485.
• Working knowledge of Quality Assurance in a medical device manufacturing.
• Holds others accountable by focusing on the right metrics, tracking results and creating transparent reviews.
• Excellent organization skills â must be able to manage a large number of simultaneous projects. 
• Attention to detail â must have precision in work completed, especially as it relates to understanding and documenting complex quality issues.
• Excellent writing skills â must be able to summarize complex issues in a clear, succinct and accurate manner. Must be able to write in a manner that effectively conveys complex issues to the reader.
• Strong communication, problem solving and motivational skills with ability to effectively communicate at multiple levels in the organization.
• Demonstrated ability to carry out assignments in a timely, accurate manner and accomplishing tasks as required with little or no supervision.

PREFERRED QUALIFICATIONS:

• Demonstrated ability to understand/ familiarity with applicable FDA regulations, and other relevant clinical/regulatory requirements.
• Class III or II medical device background in a Quality Leadership role.
• Six Sigma black belt certification.
• Demonstrated ability to create relationships, influence and move critical projects forward in alignment with key stakeholders.
• Experience working in a regulated environment required: GMPs, GLP's and GCP's.
• Strong management skills with proven leadership and team building skills.
• Demonstrated and impactful experience in process improvement (KPIV, KPOV, Fishbone, Is/Is Not, QFD), Six Sigma, product and process qualification and validation, Process Control & Monitoring (SPC).
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to travel approximately 25%, including internationally.
• Motivates the team by understanding unique needs and engages in frequent conversations and performance coaching.
• Attracts, selects, develops and manages talent for higher levels of performance.
• Assesses issues thoroughly and solves complex problems; removes roadblocks for the team.
• Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies.
• Ability to interact effectively with all levels of the organization, engage resources and perform multiple tasks in a fast-paced environment.
• Willingness to relocate and be open to global mobility assignments.

COMPETENCIES:

• Initiative
• Teamwork
• Communication
• Problem solving

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please contact your local HR department.

The base pay for this position is $144,100.00 â $288,300.00. In specific locations, the pay range may vary from the range posted.