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OMD Quality head responsible for the management of quality systems and quality assurance activities within the business unit at the Pasadena Site.
(other duties may be assigned):
- Member of the Management Team for the effective implementation of the Quality Policy and Quality Systems.
- Develops the Pasadena site quality interface documents for understanding under the umbrella Quality System Policies and SOPs across business units and sites.
- Prepares content and analysis for the periodic Quality System Executive Management Reviews.
- Develops and executes tactical quality plans, including those required for design controls.
- Leads quality improvement by providing continuing education opportunities for staff across functional areas.
- Regulatory Compliance & CAPA management.
- Quality Systems audits
- Evaluates and approves implementation of new improved quality systems tools ( e.g. electronic document management control and complaint processing CAPA, etc.)
- Reviews record retention policies & compliance.
- Reviews disaster recovery plans for configuration control (DMR, DHR)
- Reviews criteria for consultant qualification under supplier controls.
- Provides product liability support and preventive guidance.
- Approves product specification, pre- & post- clinical transfer and launch (release for sale) under design controls.
- Provides leadership and motivation necessary to meet goals set in the Management Team’s annual business plan.
- Specifies GMP/QS training requirements matrix for all company positions.
- Participates on international educational workshops, standards setting committees and professional society forums.
- Prepares and manages the assigned Quality Department budgets.
Responsible for the unit’s quality system compliance by implementing the quality policies and quality plans by driving initiatives endorsed by the Executive Management Team.
Manages the QA Staff reporting to the OMD VP-QA/RA
- Assures all products and systems comply with regulatory requirements in countries where marketed.
- Conducts internal and external compliance audits.
- Reviews product performance trends.
- Monitors reports for tracking product outgoing quality.
- Develops validation strategies and issues current guidance.
- Oversees CAPA program effectiveness.
- Participates in project teams under design controls.
- Anticipates and adapts unit’s quality system to different markets and intensified regulatory climate.
- Reports on quality & regulatory compliance issues and metrics to the VP-QA/RA.
- Prepares content and analysis for the Quality System Executive Management Reviews chaired by the VP-QA/RA.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Management skills in a technical multidisciplinary environment.
- Exhibit ethical behavior. Strong people management skills.
- Strong Communication skills.
- Strong Analytical skills.
- Strong negotiating skills.
- Solid time management skills.
- Ability to routinely interact with all levels of the company (i.e. CEO, CSO, SOO, President, VP’s, Directors, Managers, Engineers, Supervisors, Technicians, Operators)
- Bachelor Degree in a technical discipline
- 10 years of directly related industry experience in IVD and/or medical device development and manufacturing of which 5 years are in management of quality or regulatory department.
- Experience as an auditor and escort for ISO, European Directives and U.S. Quality System Regulatory Compliance inspections.
- Experience in managing quality of products for US and international markets.
- Experience as a Quality System Management Representative.
- Periodic domestic travel possible (15-20%) and possible international travel (5-10%) w/current valid passport.
Must be proficient in writing, and communicating in the English language.
Must be consistent with Bachelor degree level education and requisite experience.
Good problem solving, judgment and decision making skills are required.
ASQ Certification as CQE, CQA, and / or CQM preferred. RAPS certification as RAC or AAMI certification a plus.
Valid driver’s license and ability to obtain and/or hold current passport are required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 35 pounds. Work occasionally requires travel between buildings. This is typically completed by foot or by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood Bourne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
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