Quality Assurance Specialist III, Compliance

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.
The Hillsboro Technical Operations (HTO) Quality organization assures the compliant development and quality supply of GMP pharmaceutical products for both clinical and commercial applications, supporting Pharma Technical Manufacturing and Roche’s “right to operate”.
The focus of Hillsboro Technical Operations (HTO) is Drug Product manufacturing (Component Prep & Compounding, Liquid/Lyophilized Filling, Automated/Manual Inspection, Packaging/Finished Products and Distribution).
Job Summary: Participate in activities to enable Inspection Readiness, including facilitation of internal/external audits and managing activities to support US/exUS filings and regulatory inspections.
This position will also include managing the process for identification and mitigation of site health authority compliance risks, management of emerging regulations (including drug product, medical device and combination product production) and systematic evaluation of new requirements, oversight for trending of Quality Compliance Performance, Supplier Management and acts as a Regulatory liaison.
Responsibilities: Develop and execute inspection/audit prep plans and manage the inspection readiness activities (maintain key contact list, prep/strategy sessions, inspection readiness training, etc.
) such as manage and maintain the Inspection Ready Room, conduct post-inspection lessons learned sessions, and participate in cross site Inspection Readiness meetings Manage and facilitate internal audits/assessments, partner audits and regulatory inspections for the site such as manage and provide oversight on the response process for audits and inspections, escalate findings as appropriate, track inspection commitments to completion, perform post inspection impact assessment of findings identified from other Roche sites Manage and provide oversight on the site self-inspection program Manage the process for identifying and assessing compliance risks and track remediation activities/ action plans to closure such as conduct training for the Compliance Scoring Tool and Process and maintain the site inspection risk log and publish the Inspection Readiness scorecard in accordance to the defined global schedule Provide inputs to standard Quality reports, such as summaries for Annual Product Reviews Support creation and maintenance of documents supporting Regulatory filings, such as Site Master Files, Regulatory Maps Serve as the Compliance / Quality representative on cross-functional and multi-site teams Work and lead collaboratively within the PT Network – on project teams, network meetings, cross site initiatives, participating in other site compliance activities (i.
e.
Site Self Inspections, Network projects, Summits).
Be able to represent HTO, but also Drug Products and other positions.
Train new personnel and internal customers on relevant business processes.
Interact with senior internal and external personnel on significant matters.
Represent organization as a prime contact on initiatives and projects.
Interface with supplier quality management team to ensure supplier compliance with cGMPS and applicable regulations Maintain Quality Agreements in close collaboration with SMEs, QPLs, Contract Management group and business partners Quality and Service Level Agreements.
Support site programs and initiatives, such as Lead Production System and works to improve overall site capabilities Qualifications I Requirements: B.
A.
or B.
S.
degree (preferably in Life Science) A minimum of 5 years’ experience in a Quality role in the pharmaceutical or biopharmaceutical industry; or an equivalent combination of education and experience 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 Sound knowledge of cGMPs or equivalent regulations Flexibility in problem solving and work hours to meet business objectives Relocation benefits are available for this role.
This is an onsite role.
Full remote work or Hybrid work arrangements are not available.
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.