Sr. Manager, Quality Assurance and Regulatory Affairs Promega
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JOB OBJECTIVES: Responsible for all aspects of the PBS quality system, encompassing product quality as well as the quality of processes and services throughout the organization.
? Accountable for the development and maintenance of the Quality Management System for Promega BioSystems, Sunnyvale in compliance with ISO 13485 and 21 CFR Part 820.
? Acts as the Quality Management Representative.
? Manage QA staff involved in key processes such as CAPA, Non-conformance, Change Control, Internal Audit, Training, and Document Control.
? Represent Quality Assurance on cross-functional teams and in interactions with other departments.
? Manage both internal and external audits and maintain inspection readiness for external audits.
? Oversees interaction with the FDA and other regulatory bodies, including submissions and audits. Identifies risk areas and develop alternative courses of action including anticipation of Regulators responses through scenario planning and development of contingency plans.
? Creates regulatory strategy and policies for new products in cooperation with corporate headquarters.
? Manages all PBS regulatory strategies for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations.
? Work with the executive team and department heads to improve Quality System processes.
? Maintenance or Supervision of various Quality and Regulatory Processes:
o Supplier Quality (shared)
o Customer Complaints
o Management Review
o Change Control
o Doc Control (shared)
? Understands and complies with ethical, legal and regulatory requirements applicable to our business.
? Manage day to day regulatory affairs activities including
o Review product labeling, risk assessments, promotional materials.
o Create and manage regulatory plans for new product introductions
? The Sr. Manager QA will hold the following responsibilities:
o Assist with or lead cross departmental or corporate projects or initiatives as assigned.
o Recruit, manage and develop staff to meet departmental and business needs. Provide coaching, career development and performance expectations to staff in performance review process.
o Maintain processes otherwise assigned to the Director (i.e. Data Analysis).
o Specification and documentation review from customers.
o Review and approve Verification and Validation plans.
o Label review
o RA Activities
o Review Complaints
? Other special projects as assigned.
? Minimum BS/BA in science, engineering, or Quality Assurance related field.
? Expertise in FDA quality system regulations for medical device instrumentation companies.
? 10 or more years experience in QA/RA at a medical device company under ISO13485 and QSR.
? Expertise in Regulatory Affairs for medical devices strongly preferred.
? Thorough knowledge and understanding of US and International Medical Instrument Regulations. Experience with 510(k) submissions desirable.
? Demonstrated experience and technical understanding of development, manufacturing and quality assurance processes for life science research products.
? Ability to troubleshoot, define problems and develop solutions, and bring improvements to bear in a technical setting.
? Independent self-starter with proven analysis planning, leadership, and project management skills.
? Experience working in environments under ISO13485, or equivalent.
? Strong communication (oral and written) and computer skills.
? International professional experience.
? Excellent problem solving and decision making skills.
? Ability to work independently.
? Regulatory Affairs Certification (RAC) desirable.
? ASQ Certification desirable.
? Experience working in a QSR regulated environment.
? SAP experience.
? EtQ Reliance experience.
? Ability to work with computer equipment frequently and operate office equipment.
? Ability to sit for extended periods of time.
? Ability to move from work station to other areas of the building and between floors.
? Ability to observe and inspect equipment and operations for proper operation and compliance to safety standards.
? Ability to work in a production environment around automated equipment.
? Ability to work in an office environment utilizing a computer workstation.
? Manual dexterity and sensory capabilities to read printed data.
? The employee must occasionally lift and/or move up to 50 pounds.
This job description is not designed to cover or contain a complete listing of activities, duties or responsibilities that are required of you. It is meant to serve as a guide to the overall requirements of the position as well as the necessary qualifications.
Promega Corporation is an Affirmative Action/Equal Opportunity Employer
Sunnyvale, California, United States
||Sunnyvale, CA |
THIS JOB HAS EXPIRED