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Senior Compliance QA Specialist - Hillsboro, United States - Genentech
Description
The PositionAt 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.
The Senior Compliance QA Specialist position is part of Genentech's Pharma Technical - Hillsboro Individualized Therapies (HIT) Quality Systems (QS) team, working on various individualized modalities and is based in Hillsboro, Oregon.
In this role, you will have the opportunity to partner closely with both site and global functions.In this role, you will play a crucial part in ensuring compliance with regulatory requirements and maintaining a state of inspection readiness.
You will be responsible for a broad range of topics including, but not limited to, Quality, Safety, Health and Environmental Services (SHE), training, metrics, documenting systems and processes, the Quality Management System, audit support, and system administration.
The Opportunity:
You will support regulatory inspections, partner audits, and internal audits, ensuring site readiness and adherence to cGMPs and regulatory standards.
You will liaise with regulatory agencies, external sources, and cross-functional teams to communicate issues and contribute to the improvement of cGMP guidance and regulation.
You will lead and participate in the implementation and sustainment of Quality Systems, aligning them with cGMPs, regulatory standards, and company requirements.
You will serve as a subject-matter expert for Quality Management System (QMS) processes and systems, including deviations, CAPAs, and Quality Risk Management.
You will foster an engaging work environment, promote a continuous improvement mindset, and ensure compliance with safety, health, and environmental requirements.
You will collaborate with internal and external teams to identify and implement streamlined business and Quality processes, enabling high throughput production and analytics
You will take a leadership role in representing the HIT QS on cross-functional teams, resolving issues promptly, and driving the implementation of corrective actions to ensure continuous improvement.
Who you are:
You hold a Bachelor's degree with 8-11 years of experience or Master's degree with 6-9 years of experience, preferably in Chemistry, Biochemistry, or a related scientific discipline and have experience working in the pharmaceutical or biopharmaceutical industry
You possess technical proficiency in quality systems and strong knowledge of cGMPs or equivalent regulations to ensure compliance and patient safety
You have extensive experience audit/inspection management, including planning, hosting, facilitating, and strategy preparation
You possess excellent communication skills with the ability to influence stakeholders at all levels
You have a demonstrated ability to apply scientific principles, make informed decisions, interpret and implement Quality standards, and troubleshoot complex problems
Preferred Qualifications/Requirements:
Previous experience with Individualized Cell and/or Gene therapies
Experience with manufacturing to support clinical and or commercial production
Physical Requirements:
Work in office and laboratory environment
Lift up to 25 lbs may be required
Ability to sit, stand and move within work space for extended periods
May be required to sit at a computer terminal for extended periods
Ability to travel up to 30% to other sites as required
Relocation benefits have been approved for this posting.
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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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