At Roche, we thrive to deliver more benefits to our patients as part of our 10-year Pharma vision.We serve our patients through external partnerships because access to quality products is every patient’s right. We leverage external partners in order to offer flexibility to our internal capacity at the right cost and quality. We enable our external partners to reliably deliver compliant, quality products to our supply chain customers, so that we can deliver to patients worldwide. We do this through cross-functional collaborations ensuring quality process excellence and continuous improvement.

• Provide quality and compliance oversight of CDMOs, CROs/PET centers, and in-licensing partners to ensure compliance with cGMP and quality agreement requirements

• Must have expertise and experience in the clinical product development lifecycle, production oversight, and release of clinical supply

  • Execute all required activities to assess and release clinical supply. This includes but is not limited to review and approval of specifications, master batch records, methods, method validation reports, and executed batch records.

  • Lead resolution of complex investigations, changes and risk assessments.

  • Perform disposition of outsourced investigational medicinal products in SAP, including API and Drug Product of Synthetic Molecules and Biologics

• Serve as the Quality Point of Contact for CDMOs, CROs and in-licensing partners, and participate as a key member of cross-functional management teams to enable site selection, qualification and implementation, management, and decommissioning

• Oversee and execute all required quality activities during the lifecycle of these GMP suppliers, especially CDMOs, including but not limited to:

  • Develop, negotiate and maintain Quality Agreements and associated documents

  • Monitor cGMP compliance and report quality performance. Ensure Key Performance Indicators such as on time closure of records are met.

  • Identify and mitigate quality risks. Assess impact to Roche clinical product.

  • Support Roche audits, ensuring audit responsiveness and CAPA implementation. For Due Diligence audits, directly manage mitigation of findings prior to site implementation

  • Tech transfers and process validation, and Inspection readiness for commercial CDMOs as applicable

• Serve as Quality Point of Contact to the technical development team, and lead the Quality subteam as required. Execute the Product Specification File (PSF), intra-company agreements, approve the control system, review CMC sections of Health Authority submissions and related activities.

• You mush have a B.S., M.Sc. or PhD in life sciences or equivalent.

• At least 8 - 10 years Manufacturing and Quality experience in the pharmaceutical or biotech industry.

• Must have GMP QA experience in bulk API and Drug Product clinical supply manufacturing operations including release, preferably for Synthetic Molecules as well as Biologics including steriles. Experience with siRNA is a plus.

• Sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals. Must have the ability to interpret regulatory requirements and quality standards as they relate to clinical GMP product operations.

• Excellent Quality decision making skills in complex environments

• Proven ability to influence across cultures and functional reporting lines, and to drive continuous improvement initiatives

• Ability to operate in a self-managed way of working, with a key focus on collaboration, agility and innovation mindset

• Ability to work in a purpose driven organization, taking full ownership for assigned roles and tasks, continuously willing to improve individual and team effectiveness

• Ability to communicate clearly and professionally in English, both in writing and verbally

Travel:

• This position may require up to 10% domestic and/or international travel

Relocation benefits are not available for this posting.

We use artificial intelligence to screen, assess or select applicants for this role.

This posting is for an existing vacancy at Hoffmann-La Roche Ltd.