Quality Assurance Lead
About The Position
Roche is seeking a highly motivated Quality Assurance Lead who will be responsible for leading and executing on core US affiliate Quality accountabilities within the Medical Quality & Safety remit. This person will drive the timely execution of key outputs and activities, working in support of our strategic outcomes, and is dedicated to our organizational commitment of continuous improvement, patient safety and customer centricity. The Opportunity: Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. Facilitates internal training on quality assurance requirements, processes, and procedures. Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Provide expert Quality support to US/RDC Commercial Operations and assist the organization with testing and monitoring of conformance to established quality assurance processes and standards. Develop and implement/eliminate quality strategies, policies and processes as needed, enlisting cross-functional support to ensure RDC compliance Accountable for internal and external communications that adhere to corporate identity standards and regulatory/legal guidelines. Collaborate and establish productive cross-functional partnerships within the US and globally as business needs arise Lead or contribute to the resolution of complex quality and regulatory problems, identifying and mitigating risks Manage or support quality and regulatory audits, monitoring and/or inspections, including preparing adequate and timely responses to any inspection observations and implementing appropriate corrections, as necessary
Requirements
- Bachelor’s degree and 8+ years of quality or training/learning experience OR 12+ years of related experience
Nice To Haves
- Excellent problem-solving, customer service, negotiation, interpersonal, decision-making, leadership, and communication skills.
- Comprehensive understanding of Quality Management System regulations and policies.
- Strong analytical skills and problem-solving ability to gather data, analyze information, create monitoring tools and manage diverse information across several corporate databases, repositories and enterprise applications.
Responsibilities
- Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them.
- Facilitates internal training on quality assurance requirements, processes, and procedures.
- Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
- Provide expert Quality support to US/RDC Commercial Operations and assist the organization with testing and monitoring of conformance to established quality assurance processes and standards.
- Develop and implement/eliminate quality strategies, policies and processes as needed, enlisting cross-functional support to ensure RDC compliance
- Accountable for internal and external communications that adhere to corporate identity standards and regulatory/legal guidelines.
- Collaborate and establish productive cross-functional partnerships within the US and globally as business needs arise
- Lead or contribute to the resolution of complex quality and regulatory problems, identifying and mitigating risks
- Manage or support quality and regulatory audits, monitoring and/or inspections, including preparing adequate and timely responses to any inspection observations and implementing appropriate corrections, as necessary
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
- Benefits detailed at the link provided below.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
