The Position

In External Quality 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 and we do this through cross-functional collaborations ensuring quality process excellence and continuous improvement. Do you enjoy working and collaborating globally? Do you like investigating and solving issues? Are you ready to make a difference? The position contains the following key responsibilities:

Technical Job Responsibilities

• Oversee all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage, and Decommission), including but not limited to: process or method validations, Roche and Health Authority audits, complex investigations, market complaints, and regulatory submissions. Main focus on QC activities at contract manufacturing, supporting QC troubleshooting.

• Lead critical investigation related to Quality Control in Large Molecule sterile domain.

• Develop, negotiate and maintain risk-based Quality Agreements and Product Specific Requirements (as appropriate) with GxP suppliers and ensure compliance with agreements.

• Collaborate with GxP suppliers to address gaps of audit responsiveness, CAPA implementation, deviation reporting and management, complaint management, investigation closure, and change implementation with regard to quality and time with the supplier; and escalate as appropriate.

• Manage all required activities to support Make Assess Release (MAR) of commercial medicinal products including approval of master process documentation, resolution of investigations, assessment of changes, and monitor and report GxP Supplier quality performance.

• Release, reject or quarantine commercial medicinal products (drug substance or API, bulk drug product, and semi-finished and finished products) and medical devices produced within the area of responsibility per applicable Swissmedic and Roche requirements on behalf of the Responsible Person (RP).

• Collaborate with GxP suppliers to maintain the manufacturing processes and the Specifications and Analytical Methods (SAM) in a validated state and compliant with the regulatory dossier, including stability testing programs.

• Develop and maintain quality risk management plans; utilize risk management tools to identify and mitigate supplier quality and compliance risks, ensuring suppliers are in a state of continuous inspection readiness.

• Manage or lead technical transfers for manufacturing, testing, packaging, and product launches.

• Support or lead supplier improvement initiatives to solve complex manufacturing or quality problems. Identify, design and implement process and system improvements.

Functional Job Responsibilities

• Collaborate and manage relationships across supplier management and internal cross-functional teams to ensure quality expectations are aligned with Roche objectives.

• Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance.

• Troubleshoot and drive the resolution of quality issues, fostering effective interdepartmental and cross-functional partnerships.

• Sign documents as authorized and described by Roche policies, procedures and job descriptions.

• Be accountable for behaviors described in Roche’s Code of Conduct.

• Deliver business outcomes in support of departmental objectives.

• Maintain and communicate work priorities to meet goals and timelines.

• Timely complete all job-related training requirements prior to performing GMP-job functions and strive to continuously improve on knowledge and skills in quality, compliance and technology.

• Communicate new and updated regulatory requirements and applicable Roche expectations to GxP suppliers as applicable, and evaluate systems in place.

• Perform other quality related activities and projects in order to ensure quality and compliance and enable continuous improvement.

• Identify, support and/or lead continuous improvement initiatives that may benefit External Quality and other organizations.

• As applicable, deputize for the GxP Supplier Management Chapter Lead or a peer and assist with their duties if and when required.

• May mentor and/or coach colleagues within and outside the organization.

Qualifications and Skills

• Ideally, a B.A. or B.S. degree in life sciences or equivalent.

• Previous experience in the pharmaceutical or related industry or an equivalent combination of education and experience. Experience with GxP suppliers such as CMO, CLO and direct material suppliers as well as QC skills in sterile products is a plus.

• Sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals.

• Ability to interpret quality standards as they relate to GxP suppliers.

• Operational Excellence expertise is a plus.

• Highly competent in MS office or Google Suite applications including Excel, PowerPoint, Word, and MS Project, etc.

• Ability to communicate clearly and professionally both in writing and verbally.

• Fluency in oral and written English is a must. Additional language skills are a plus.

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

Who we are

At Roche, more than 100,000 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.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.