Senior/Principal QA Specialist, Lot Disposition

The Position

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients’ lives. We are courageous in both decision and action; we believe that good business means a better world. Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work. Organization Overview Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products. The Operations organization at HTO is divided into 2 value streams, which combine to produce millions of units of life-saving medicine every year to patients around the world. Job Summary: In this exciting role, you will be part of a dynamic and inclusive team. You will perform batch disposition activities for products produced at Genentech's Hillsboro, OR facility in accordance with established processes and procedures, performance metrics and adherence to schedule. You will partner with stakeholders at the site and in the network. You will be a mentor and coach for the organization and the network and you will develop, coordinate and communicate solutions for complex Quality System issues that impact multiple functions, working knowledge and application of cGMP regulations and standards, understanding inter-organizational impact at the Hillsboro site and the network. Technical Job Responsibilities Manage batch disposition activities to ensure that products are dispositioned in accordance with cGMPs, Regulatory, and Genentech Policies and Procedures and while maintaining adherence to schedule. This includes cross functional collaboration at the site and with the global Roche/Genentech network to ensure that batch disposition items meet our standards and the final review and approval of batch release documentation.

Notify senior management of potential quality or regulatory issues that may impact product quality or regulatory compliance and all known delays

Perform reviews of investigations for potential cumulative effect to product quality

Interact with interdepartmental contacts on discrepancy assessment, resolution, and Quality approval

Has in-depth conceptual and practical knowledge in the quality functional area and basic knowledge of related areas at a manufacturing site and within the network.

Communicate new and updated regulatory requirements and evaluate systems in place.

Support internal cGMP audits and Health Authority inspections as needed, and follow up on any corrective measures.

Solves complex problems

Works independently within standard guidelines, policies and health authority regulations, receives minimal guidance from others

May lead projects

Acts as a resource for colleagues with less experience and provides functional guidance to peers and other leaders

Serves as primary consultant to senior management and internal/external spokesperson for the organization on significant matters pertaining to issues, policies, programs, practices and objectives.

Interactions require tact and effective communication skills as they often involve complex and sensitive information.

Job Duties / Responsibilities Be accountable for behaviors described in Roche’s Code of Conduct

Deliver business outcomes in support of departmental objectives. Maintain and communicate work priorities to meet goals and timelines.

As part of an agile organization, flow to work and apply skills where resources are needed

Complete all job-related training requirements prior to performing GMP-job functions and strive to continuously improve on knowledge and skills in quality, compliance and technology.

Identify, support and/or lead continuous improvement initiatives that benefit the Hillsboro site and other organizations.

As applicable, deputize for the QA Value Stream Head or a peer and assist with their duties if and when required.

Mentors and/or coaches colleagues within and outside the organization.

Qualification and skills BS/MS Master's degree (Life Sciences or Engineering, preferred)

For Senior QA Specialist level, 8 - 11 years experience. Principal QA Specialist level 12 - 15 years of experience in the pharmaceutical or related industry (Minimum of 5 years experience in a GMP Quality role)

Expertise in GMP Drug Product and/or Drug Substance production for Biologics is preferred.

Has developed a variety of skills typically gained through years of professional experience.

Recognized internally as an expert in own job discipline. Has deep skills and expertise across multiple disciplines in the field.

Sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals. Ability to interpret quality standards as they relate to commercial manufacturing.

Must be able to gown into production space

Excellent verbal and written communication skills

Strong interpersonal skills, diplomacy, and negotiation skills to influence and accomplish business objectives

Excellent influencing and negotiating skills when interacting with stakeholders at all levels within Roche worldwide operations.

Adaptability to new ways of working, and an agile and innovative mindset.

Ability to work in a purpose driven organization, taking full ownership for assigned roles and tasks, continuously willing to improve individual and team effectiveness.

Fluency in oral and written English is a must. Additional language skills are a plus.

This position is eligible for relocation benefits. It is not eligible for full time remote work arrangements. Link to Roche/Genentech

Benefits Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

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