- Responsible for ensuring commercial and clinical (IMP) products fulfill the specified requirements and they are released in legal compliance with the customer markets, regulatory filings, as well Roche quality requirements.
- Review and approve procedures, master batch records, and other QA-controlled documentation and associated change control.
- Responsible for lot disposition and release of commercial and clinical products according to the approved registration dossiers, ensuring internal standards are achieved and in compliance with local and international laws (e.g., Qualified Person/ Responsible Person).
- Create or revise quality documents. Provide Quality oversight for processes and procedures related to operations.
- Support and lead cross-functional projects and Quality initiatives. Identify and participate in the resolution of Quality risks and issues by fostering effective interdepartmental and cross-functional relations.
- Partner with functional areas to resolve product quality impacting investigations and own CAPA related to area of responsibility.
- Embody PT lean principles and methods while fostering a continuous improvement mindset.
- Provide Quality Assurance oversight throughout the end-to-end production operations including Chain of Custody and Chain of Identity, assuring current GMP compliance.
- Participate and support internal and external audits. Serve as Subject Matter Expert to defend lot disposition practices, batch records, and reports Review and approve QA documentation to ensure GMP compliance to all relevant regulations. Ensure documentation supports a continuously compliant state at HIT and a continual state of readiness for their areas of responsibility for agency inspections.
- Responsible for monitoring and continuous improvement for relevant Quality key performance indicators
- Management of deviations & CAPA, ensuring robust, thorough and complete investigations (including root cause analysis, product quality impact, interim/mitigating/long term actions and documentation). Provide the appropriate oversight and support the implementation of the actions through appropriate records, timely resolution, action, and closure of the quality system records and their effectiveness.
- Assist in building a process for complaint management execution, including oversight of complaint intake, timely evaluation, trending and issue escalation.
- Manufacturing, all Site functions, PTD, Affiliate Quality Assurance Management, Regulatory (PTR)
- Global Quality System and Quality Management, External Quality, Supplier Quality, partners, key suppliers and CMO
- You hold a Bachelor's Degree (Pharmacy, Pharmaceutical, bioengineering, Chemistry or other relevant area preferred)
- 6 or more years of work experience in the pharmaceutical or related life science industry
- A minimum of at least 8 years of experience in Quality Assurance, Quality Control, Manufacturing, or equivalent experience
- Expert knowledge of Quality Assurance principles, practices and standards for the biopharmaceutical industry
- Demonstrate excellent problem-solving skills, tactical strategy, and diplomacy.
- Able to independently resolve issues of high complexity and effectively lead cross-functional initiatives with broad scope. Influence extends beyond the local area to network or groups outside of HIT.
- Experience with Individualized Medicine (ATMP)
- Familiarity with computer systems and the ability to quickly become familiar with new software (e.g., EDMS, LIMS, SAP) is highly desirable.
- Expert knowledge of GMP(Good Manufacturing Practice) relevant to the pharmaceutical industry, knowledge of local and international GMP regulations, and knowledge of regulations related to ATMP (Adavance Therapy medicinal Products) is desirable.
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Senior Quality Assurance Specialist - Hillsboro, United States - Genentech, Inc
Description
External Job Ad TextA healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.
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.
The Opportunity:
This position is part of Genentech's Pharma Technical—Hillsboro Innovative Therapies and Cell Therapy team, which is based in Hillsboro, Oregon. In this critical role, you will be part of a dedicated cross-functional team working on production start-up activities and tech transfer of new programs, helping to implement the quality approach for these exciting and novel technologies.
This position is located on-site in Hillsboro.
Shift flexibility and/ or rotation are necessary for this successful applicant. (Primarily weekend and swing shifts, as well as some day shifts)
Key Responsibilities:
Technical and Functional:
Key Interfaces:
Who you Are:
Preferred Skills:
Relocation benefits are approved for this position.
The expected salary range for this position, based on the primary location of Oregon, is $91,100 -$169,100 of the hiring range. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
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.
