Abbott · 17 hours ago
QA Director, Commercial and Affiliate
Temecula, CA
Full-time
Onsite
Director/Executive
$149K/yr - $299K/yr
16+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. The QA Director, Commercial and Affiliate will develop and maintain operational quality assurance programs, ensuring compliance with established standards and agency regulations while providing leadership for quality policies and practices.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
Responsibilities
Define and communicate overall vision and cascaded objectives for the departments
Provides overall leadership for Quality policies, approaches, and standard practices. Maintains alignment with US and International regulations and standards, as well as Abbott quality systems
Responsible for AV Quality Commercial Excellence PMO, globally. The incumbent is responsible for oversight of quality practices for the commercial organization. This includes the development, implementation and maintenance of systems around commercial distribution of Vascular products, and quality responsibilities for distributors/in-country partners and affiliates around the world who distribute product and/or take customer complaints. The incumbent will take a proactive approach ensuring that all regulatory requirements and company QA policies and procedures are met as part of any commercial launches and/or applicable pilot program discussions
The role also has responsibility for active participation on the CAPA Review Board for internal Exception Reports, Corrective Actions and Investigations. The incumbent will also play a key role in external inspections/audits that take place in the across commercial affiliates or Corporate Audit. This position also provides support for development and implementation of any required corrective action plans resulting from affiliate audits
Some functional site responsibilities may require providing high level direction of all activities related to calibration of measurement equipment used throughout the organization in accordance to policy, including equipment traceability, out of tolerance management, and interval management
Assures Quality provides technical support and services to Operations and Research & Development functions. Supporting approved projects and objectives of both functions
Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc
Be a champion of Quality, Lean and disciplined problem solving throughout the organization to identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility
Provide influential leadership with US and OUS sites to drive proactive quality improvements and harmonization
Provide diligent and fact-based communication to Executive Management team, peers, and team
Provide management and development of the Quality staff
Be an effective member of the cross-functional Director organization to foster continuous quality compliance, cost, and predictive measures improvements by maintaining effective Quality Metrics and define and execute activities to resolve decreases in performance
Support all Divisional initiatives as identified by 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
Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, including EN ISO 13485, 21CFR 820 Quality System Regulation, MDD, JPAL and CMDR
Ensures that product acceptance activities are handled in a manner that complies with all pertinent regulatory requirements. Reports on the performance of the quality system
Qualification
Required
Bachelor's degree + 16 years experience
Minimum 10 years in quality desired with at least 3+ years management of demonstrated compliance excellence, value improvement, risk reduction, and cost containment
Demonstrated ability to understand/ familiarity with applicable FDA and TUV regulations, and other relevant clinical/regulatory requirements. Class III or II medical device background in a Quality Leadership role. Quality System Regulations knowledge (ISO 9001, ISO 13485)
Strong leadership skills with demonstrated ability to create momentum and deliver excellent results. Strong organization, speaking skills, and influential management ability. Ability to work in a highly matrixed and geographically diverse business environment. Ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results
Ability to work effectively within a team in a fast-paced changing environment. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multi-tasks, prioritizes and meets deadlines in timely manner. Strong organizational, planning, and follow-up skills and ability to hold others accountable
Preferred
Master's Degree Preferred
Benefits
Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan.
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Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
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