Hillsboro Intern- Pharma Technical Operations- Compliance Hillsboro Oregon, United States of America Job ID:201806-108440 -The Position Provide strategic direction and manage execution of regulatory inspections, internal and external audits and paper-based inspections. Provide strategic direction and oversight for the establishment and execution of the site self-inspection program. Ensure the program drives continuous improvement of the sites systems, processes and operational performance. Develop, lead, and execute inspection readiness activities for site Accountable for the response process and follow up on the mitigation activities, including coordination and interface with Global Functions and/or network sites as required. Manage the compliance risk program, including education of the site around new requirements, compliance trends. Lead Supplier Management, including Direct Materials and Medical Devices: responsible for the monitoring of local suppliers compliance with the requirements of cGMPs and applicable regulations, perform audits of external locally managed suppliers and/or interface with SQM team as defined by site. Establish, negotiate and maintain Quality Agreements in close collaboration with SMEs, Contract Management group and business partners Quality and Service Level Agreements. Liaison with PT Regulatory, lead coordination between site and PTR in close collaboration with site QA and site QS/QV. Supports Site Quality Head in terms of compliance questions, works together with other departments e.g. local manufacturing site, global functions like GQIM, External Relations. Interface with Affiliates to maintain import license The project will include: -Assist in the creation of a global Health Authority Requirements matrix for the purposes of overall Compliance at Hillsboro Technical Operations (HTO), and targeted assessments of Compliance through formal and informal requests. -(Subproject): Support paperless inspection initiative by detailing use case scenarios, under supervision -(Subproject): Participate in weekly PIRT meetings and support activities as requested. -Document meeting minutes, if necessary -Observe cross-functional Inspection Readiness communication -(Optional Subproject): Compliance team webpage design -Observe Compliance inspection readiness activities (maintain key contact list, prep/strategy sessions, inspection readiness training, etc.) -Management and maintenance the Inspection Ready Room -Conduct of post-inspection lessons learned sessions -Participation in cross-site Inspection Readiness meetings Qualifications -Minimum of an Associates degree (or Associates pending completion of internship) from an accredited institution.Education in science, engineering, or other technical fields is preferred. -Highly self-motivated, and well organized; sound decision making skills -Ability to develop solutions to a variety of complex problems and initiatives -Ability to communicate clearly and professionally both in writing and verbally -Ability to interpret Quality standards for implementation -Some knowledge of cGMPs or equivalent regulations -Flexibility in problem solving and work hours to meet business objectives -Preferred: familiarity with webpage design -Who We Are A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work. The next step is yours. To apply today, click on the "Apply online" button. Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit ourGenentech Careers page. -Job Function Internship -Location -Hillsboro Oregon, United States of America -Company/Division Pharmaceuticals -Schedule Full time -Job type Temporary (Fixed Term)