Basel is the headquarters of the Roche Group and one of its most important centers of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites.
The Global Quality Systems & Operations organization in Pharma Technical Quality (PTQ) is the owner of the PT Pharmaceutical Quality System (PQS).
The Global Quality Standards Technical Lead position is a strategic role and is responsible for Quality ownership and oversight of Global PQS documents for IMP and Commercial Manufacturing, providing objective quality & technical expertise and establishing pragmatic global quality standards that meet current and future needs. The Quality Technical Leaders serve as subject matter experts for areas of responsibility related to Quality Systems, Technical, Validation, Manufacturing Controls, and Medical Devices.
In this role you will work cross-functionally with Technical Research and Development (TR&D), the PT manufacturing sites, and other PT functions to influence and shape the Global PQS documents. You will provide leadership for quality oversight, and work with individual sites and functions to incorporate industry trends and regulatory requirements to develop best practices for execution.
The scope of accountabilities comprises but is not limited to the following tasks:
Author and/or approve, implement, and sustain global PQS requirements and standards in collaboration with stakeholders across the network
Understand and ensure that applicable regulatory requirements are incorporated into the global PQS
Enable the global PQS to meet evolving business and regulatory needs, and ensure sufficient flexibility for TR&D to deliver the Roche pipeline
Provide guidance to network on interpretation, implementation, and gap remediation of global PQS requirements and best practices for maintaining a quality program
Foster interdepartmental and cross-functional partnerships across the Roche network
Provide technical support as required to ensure understanding and execution of global Quality processes and procedures. Identify, facilitate, and resolve cross-site and cross-business unit Quality system issues
Strategize and standardize practices where practical across the network
Influence externally by contributing to publications, industry forums, and conferences
Lead or provide technical and quality expertise to support internal audits, Health Authority inspections, and global regulatory responses.
Lead or provide technical and quality expertise to projects and network teams to mitigate inspection risks, help define strategies, and drive continual improvement in the global PQS.
Highly self-motivated, well organized, possessing a solution oriented and continuous improvement mindset
Proven track record of successfully planning, implementing, and tracking of global/highly complex projects on time and within budget
Excellent negotiation, collaboration influencing, and decision making skills in a cross-functional matrix organization, specifically across cultures, countries, and organizational levels
Flexibility in problem solving and providing direction to meet business objectives
Ability to innovative when faced with opportunities or challenges
B.A. or B.S. degree and at least 10 years of experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experience
Current working knowledge of cGMPs, ICH guidances, ISO standards, and regulatory and industry technical standards relative to clinical (IMP) development and/or commercial
A recognized and respected leader with significant experience / expertise in at least one of the following areas: Quality Systems, Technical, Qualification, Validation, Manufacturing Controls (Biologics or Small Molecules), or Medical Devices (including aseptic processing, maintenance, calibration, HVAC, environmental monitoring, gowning, maintenance, calibration, facility fitness, design control)
Experience in new modalities/advanced therapies (individualized/targeted, cell/gene therapies, software as a medical device) is a plus
Experience working in manufacturing field or in product / process development are preferred
Practical experience with Quality Systems development and implementation, including risk management
Strong written and verbal communication skills in English (German language skills is a plus); ability to present clearly and concisely to a broad audience including technical teams, senior leadership, and external partners
Ability to travel (<10%)