Manager Quality Assurance

NAMSA•Irvine, CA

20h•$98,600 - $135,000

About The Position

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas. Job Description: • Responsible for management of site Quality functions in support of Laboratory Services activities (may include GMP and/or GLP testing), including oversight and training of QA staff. Performs and supervises QA activities performed under the requirements of ISO 17025, as required. • Provides oversight for GLP study Quality Assurance activities as defined in 21 CFR Part 58.35. Ensures that systems are designed and implemented to: o Monitor studies and maintain knowledge to ensure compliance with the protocol, Standard Operating Procedures (SOPs), and GLP regulations as they apply to the preclinical research environment and duties related to research operations. o Management of protocol/procedural deviations. o Maintenance of GLP Master Schedule and study protocols. o Review of final study reports to ensure accuracy. • May review and approve Standard Operating Procedures and/or Test Methods. • May manage Document Control function and site Archives, as required. • May have management of the internal audit program; standards include 21 CFR Parts 58, and 820, and ISO 17025. • May participate in or manage regulatory agency inspections and certification/accreditation body audits. • May have QA oversight of calibration and maintenance programs. • Directs and manages daily quality operations, which may include laboratory investigation programs, including unexpected results and testing nonconformance, testing complaints, and corrective actions, as applicable. • May manage client and regulatory body activities related to the lab and lab tests. • May be responsible for the timeliness, measurement and effectiveness of operational processes; establishes goals and metrics enabling frequent updates to the management team. • Ensures and oversees the effectiveness of team training programs. • Review of protocols and reports, which may include client testing, method validation, equipment/facility/utility qualification, and computer system validation (regulated systems). • May oversee Proficiency Testing Program in support of ISO 9001 or ISO 17025 accredited methods. • May serve as site Management Representative with respect to ISO 13485, ISO 17025 standards and 21 CFR 820.20, ensuring compliance with the requirements of these and other pertinent quality standards. • Developing and managing departmental budget. • Other duties as assigned. • Acts as back-up Quality System Management Representative. • Assist with orienting Associates on the QS and providing the 21 CFR Parts 58 and ISO 9001 Overview Training. • Negotiates technical, schedule and quality issues with the client and utilizes Senior • Assist with facilitating external audits of NAMSA China by clients, FDA and ISO registrar. • Responsible to plan, organize, start-up and manage the ongoing operations of quality assurance department, including equipment, supply, staff and work space needs. Works with management to solve capacity issues and to plan for capacity expansion. • Acts as CAPA Coordinator for QS CAPAs by initiating CAPAs as needed, investigating CAPAs, implementing CAPA actions, working with appropriate Associates to complete CAPA actions, and closing CAPAs. • Acts as back-up Complaint Coordinator. • Develops and tracks quality systems metrics for: 1) reporting to the Senior Management Team at Quality Management Reviews and 2) supporting business development activities. • Identifies opportunities and determines and implements solutions to continuously improve quality system (e.g. training, mentoring, systems, etc.). • Oversee the Document Control Department. • Oversee Records Management. • Participate in and deliver presentations in meetings with prospective clients. • Identifies/develops new clients and revenue streams. • Pursue and capture additional areas for market penetration. • Speak at National conferences, webinars or other marketing venues • Prepare estimates. • Offer opportunities to clients for additional services to be provided.

Requirements

Minimum of Bachelor’s degree or equivalent experience in a related field required.
Minimum of 10 years of relevant experience including 5 years supervisory experience and Project Management experience.
Regulatory Interface and P&L experience required.
Fluency in English and local language, if different, required.
Must maintain strong knowledge of GLP and ISO 17025 regulations and the ability to interpret and apply these to daily work.
Experience responding to NMPA/FDA/EU/ISO deficiency responses.
Experience budgeting and working with senior management at a client.
Certifications/Licensures in RQAP-GLP, ISO17025 audit certification, ASQ Quality Auditor or Quality Manager

Responsibilities

Responsible for management of site Quality functions in support of Laboratory Services activities (may include GMP and/or GLP testing), including oversight and training of QA staff.
Performs and supervises QA activities performed under the requirements of ISO 17025, as required.
Provides oversight for GLP study Quality Assurance activities as defined in 21 CFR Part 58.35.
Ensures that systems are designed and implemented to: o Monitor studies and maintain knowledge to ensure compliance with the protocol, Standard Operating Procedures (SOPs), and GLP regulations as they apply to the preclinical research environment and duties related to research operations. o Management of protocol/procedural deviations. o Maintenance of GLP Master Schedule and study protocols. o Review of final study reports to ensure accuracy.
May review and approve Standard Operating Procedures and/or Test Methods.
May manage Document Control function and site Archives, as required.
May have management of the internal audit program; standards include 21 CFR Parts 58, and 820, and ISO 17025.
May participate in or manage regulatory agency inspections and certification/accreditation body audits.
May have QA oversight of calibration and maintenance programs.
Directs and manages daily quality operations, which may include laboratory investigation programs, including unexpected results and testing nonconformance, testing complaints, and corrective actions, as applicable.
May manage client and regulatory body activities related to the lab and lab tests.
May be responsible for the timeliness, measurement and effectiveness of operational processes; establishes goals and metrics enabling frequent updates to the management team.
Ensures and oversees the effectiveness of team training programs.
Review of protocols and reports, which may include client testing, method validation, equipment/facility/utility qualification, and computer system validation (regulated systems).
May oversee Proficiency Testing Program in support of ISO 9001 or ISO 17025 accredited methods.
May serve as site Management Representative with respect to ISO 13485, ISO 17025 standards and 21 CFR 820.20, ensuring compliance with the requirements of these and other pertinent quality standards.
Developing and managing departmental budget.
Other duties as assigned.
Acts as back-up Quality System Management Representative.
Assist with orienting Associates on the QS and providing the 21 CFR Parts 58 and ISO 9001 Overview Training.
Negotiates technical, schedule and quality issues with the client and utilizes Senior
Assist with facilitating external audits of NAMSA China by clients, FDA and ISO registrar.
Responsible to plan, organize, start-up and manage the ongoing operations of quality assurance department, including equipment, supply, staff and work space needs.
Works with management to solve capacity issues and to plan for capacity expansion.
Acts as CAPA Coordinator for QS CAPAs by initiating CAPAs as needed, investigating CAPAs, implementing CAPA actions, working with appropriate Associates to complete CAPA actions, and closing CAPAs.
Acts as back-up Complaint Coordinator.
Develops and tracks quality systems metrics for: 1) reporting to the Senior Management Team at Quality Management Reviews and 2) supporting business development activities.
Identifies opportunities and determines and implements solutions to continuously improve quality system (e.g. training, mentoring, systems, etc.).
Oversee the Document Control Department.
Oversee Records Management.
Participate in and deliver presentations in meetings with prospective clients.
Identifies/develops new clients and revenue streams.
Pursue and capture additional areas for market penetration.
Speak at National conferences, webinars or other marketing venues
Prepare estimates.
Offer opportunities to clients for additional services to be provided.