Quality Assurance Manager(Operations) at Roche

Job Description: Role and Responsibilities

• The Quality Manager – Operations Quality will be a strong partner to the Global Quality and Regulatory function, as well as across the various Roche business functions, including Operations, Supply Chain, and Logistics.
• Responsible for managing, developing and implementing Quality Management System (QMS) elements and supporting infrastructure/tools in compliance with International Standards Organization (ISO) regulations, and Roche corporate requirements.
• Is able to analyse QMS elements/processes and derive procedures to drive compliant implementation. Supports Roche Molecular Solutions quality, operations and supply chain departments and efficiency initiatives by providing technical support and guidance across organizations, sites, levels, and groups.
• Functions as leader or internal consultant for identification, execution, and implementation of CAPAs, nonconformances, validation and process improvement activities, and change requests, as appropriate.
• Leads the development and distribution of key performance indicators (KPIs) in alignment with Quality Objectives and operations goals.
• Utilizes Quality Engineering tools and services provided through project work or training such as: Experimental study design (DOE); Sampling plans (acceptance sampling and experimental sampling); Failure investigation data analysis (e.g. ANOVA, F&T testing, basic data charting).
• Leads or participates in internal, external, supplier, and shop floor auditing programs as appropriate.
• Assures local organization is trained in the use of Quality tools in support of process improvement initiatives (e.g., FMEA).
• Performs Validation/Qualification document review and approval, ensuring compliance with ISO and Roche guidelines and requirements.
• Expected to operate independently, holding him/her accountable to proactively fulfil tasks and achieve results within assigned timelines.
• HR responsibility for direct and/or indirect reports, which may include hiring/termination decisions, interviewing, selection, performance feedback, discipline, pay decisions, and handling employee grievances/complaints.

Qualifications and Education Requirements

• Bachelors’ degree in Biological Sciences, Engineering or related field, or equivalent combination of education and work experience.
• 7+ years of relevant medical diagnostic/device industry/regulated pharmaceutical or biotechnology experience, including minimum of 5 years of direct Quality Engineering or Quality Operations
• 5+ years of people managing experience
• Experience focused on quality systems, regulatory affairs/compliance, project management, controlled documentation, and/or change control.

Preferred Skills

• Master’s degree or equivalent.
• Thorough working knowledge of relevant international ISO Standards (13485, 14971) and regulations (European medical devices directives) would be advantageous.
• Statistical training, ISO 13485:2016 Lead Auditor training and/or Six Sigma Green/Black Belt
• Enthusiasm for the role that Quality and Regulatory (Q&R) can play in enabling the development of new products for our patients.
• Drive to engage positively with Q&R/Business teams and make impactful contributions in a multicultural/national environment.
• Track record of providing sound Q&R judgment/ideas and business partnering.
• Strong leadership/interpersonal/integrating/problem-solving skills and demonstrated ability to collaborate effectively across a variety of workgroups in demanding/changing situations (medical, scientific, and manufacturing).
• Strong communication skills with both internal and external customers, with ability to get points across clearly and simply