Senior Specialist and Site DI Lead, Quality Assurance
Lead site Data Integrity maturity and computerized systems validation to directly impact the quality and compliance of life-saving biopharmaceutical manufacturing in Bend, OR. This is a site-based role with limited flexibility. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. We offer flexibility to work remotely for no more than 20% of your time. Requests are considered on a case-by-case basis, in line with business needs.
What you will get:
An agile career and dynamic working culture.
An inclusive and ethical workplace.
Competitive hourly rate / compensation package.
The hourly/daily rate for this position is expected to range between [$45 - $50]. Compensation for this role will be determined by the candidate?s qualifications, skills, experience, and relevant knowledge.
What you will do:
Drive site-wide Data Integrity (DI) culture, governance, and maturity roadmap across operational and quality teams.
Collaborate with IT, Quality Control, Automation, QA, and external vendors to review and approve qualifications and validations.
Lead commissioning, qualification, and computerized system validation (CSV) projects for equipment and laboratory instruments.
Author, review, and approve validation protocols, execution reports, and life-cycle documentation.
Serve as the subject matter expert during regulatory inspections and client audits regarding validation strategies and DI standards.
Establish and lead regular site DI forums and structured GEMBA walkthroughs to proactively address potential compliance risks.
Perform change and risk management assessments, assisting with deviations, root cause analyses, and CAPA implementations.
What we are looking for:
Bachelor?s degree in a scientific field (minimum required).
Minimum 5 years of experience in the pharmaceutical or biotechnology industry, including at least 2 years within a Quality Unit.
Proven experience with equipment and analytical instrument qualification as well as computerized systems validation (CSV).
Strong working knowledge of GxP regulations, 21 CFR Part 11, Annex 11, and applicable USP standards.
Demonstrated experience conducting risk assessments, gap analyses, and investigations within quality management systems.
Strong cross-functional communication and leadership skills to facilitate site DI initiatives and train operational teams.
About Lonza
At Lonza, their people are their greatest strength. With 30+ sites across five continents, their globally connected teams work together every day to manufacture the medicines of tomorrow. Their core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who they are and how they work together. Everyone?s ideas, big or small, have the potential to improve millions of lives, and that?s the kind of work they want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, they value diversity and are committed to creating an inclusive environment.
As Lonza?s talent acquisition partner, please note, Randstad is responsible for the engagement and contracting of this contingent role.
Ready to play your part in shaping the future of life sciences? Apply now.
