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Holly Springs, North Carolina, United States
Onsite
At Roche, we believe it’s critical to deliver medical solutions now – even as we develop innovations for the future. We are passionate about transforming patients’ lives and we are fearless in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigour, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.
As a vital member of our global Manufacturing Science & Technology (MSAT), Engineering & Sustainability Team (PTT) you will ensure the integrity and compliance of our digital validation system and processes in accordance with cGMP regulations and Roche’s standards. This senior role involves developing, implementing, and maintaining innovative validation strategies, optimizing Qualification/Validation business processes, and resolving complex technical challenges across the global network. By collaborating with MSAT, Engineering, Quality, and IT organizations, you will act as a technical leader and network collaborator to drive the implementation of effective, compliant solutions across the enterprise.
Drive and implement sustainable digital validation system strategies in collaboration with global teams across Roche and affiliates to ensure compliance with cGMP regulations and Roche standards.
Optimize and build Qualification/Validation business processes, create and maintain validation documentation standards in close collaboration with Process Owners and site Business Process managers to ensure they align with regulatory requirements, industry best practices and Roche standards.
Collaborate with cross-functional experts and leaders, including Quality, Manufacturing, Engineering and IT, to ensure harmonized and effective qualification and validation.
Act as a primary thought partner to senior management, translating complex technical validation challenges into actionable strategic insights.
Spearhead enterprise-wide change management and training programs to accelerate the adoption of advanced validation systems and principles.
Translate the aligned business processes into master data and manage the end-to-end lifecycle of master data and templates within the Validation System, ensuring communication and seamless deployment across the global network
Lead risk assessment initiatives to proactively identify system compliance issues and architect robust mitigation plans for global manufacturing sites.
Who you are
Education: Bachelor's or Master's degree in Engineering, Life Sciences, or a related technical field is preferred.
Professional Experience: 10+ years of experience in the pharmaceutical or biotechnology industry, with a focus on process development, manufacturing operations, or validation with experience in systems management in the pharmaceutical or healthcare industry.
Leadership: Proven track record in matrix leadership, cross-functional team management, or direct people management, with a high ability to collaborate globally and with a diverse team location.
Regulatory Expertise: Knowledge of FDA (CFRs), EMA, and ICH regulations, specifically regarding 21 CFR Part 11 compliant GMP environments.
Validation Mastery: Advanced proficiency in qualification and validation business processes, risk assessments, and technical documentation.
System Expertise: Experience with ValGenesis or similar Validation Lifecycle Management Systems (VLMS) is highly preferred.
Project Management: Demonstrated ability to lead enterprise-level projects from requirements analysis through to system design and implementation.
Decision Making: Capability to role model effective risk-taking and decisive action in complex, ambiguous environments.
Coaching: Ability to act as a mentor and coach for colleagues, fostering technical growth and professional maturity.
Communication: Excellent presentation skills with the ability to synthesize complex data into actionable summaries for diverse audiences.
Travel Requirements:
Anticipated domestic and international travel: 20%
Relocation benefits are not available for this posting.
The expected salary range for this position based on the primary location of Holly Springs, NC, is $114,400 to $212,400. 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.
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Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
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