Compliance and External Collaboration Manager
Who we are?
At Roche, we believe it is urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. In addition, we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world.
Would you like to join our team, and more specifically, our Quality function?
Quality allows us to deliver high-quality products to patients, ensures our right to operate, and helps us bring value through process excellence and continual improvement efforts. Quality is a competitive advantage for Roche. Innovation, efficiency and quality are at the heart of all we do. The PTQE (Pharma Technical Operations Quality External Collaboration) team Europe is an integral, strategic function for advancing Roche Regulatory Intelligence and Policies in key areas such as Development, Regulatory filings (MA and Post-approval), GMP, PQS and various business projects.
Are you seeking for a meaningful role in Quality?
As the Global Compliance and External Collaboration Manager, EMEA, you lead and build Roche Pharma Technical Operations (PT) External Collaborations efforts and regulatory policy and strategy activities for Quality and GMP/GDP topics. You engage with internal and external partners, including Regulatory Agencies and Regional Industry Associations, and are primarily responsible for:
- Assessing and developing Roche position on emerging Regulations and monitoring /analyzing Industry Quality and GMP/GDP compliance trends globally
- Providing initial assessment, interpretation and communication of potential and actual operational impacts of evolving, critical and/or strategic Quality and GMP/GDP Regulations
- Identifying, analyzing and communicating critical/ global Regulatory and Industry trends, developments and related topics of interest to senior leaders and key partners
With focus on external topics critical to enabling the Roche Policies, your main responsibilities are:
- Lead External Collaboration Policy and Strategy activities in Quality, including Global Inspection and Compliance
- Actively participate and/or lead committees in Roche External Interaction Steering Committee sanctioned trade and individual member associations related to quality initiatives, regulations, and conferences
- Identify, analyze and communicate all meaningful external activities in the GMP –GDP area and ensure finalized regulatory requirements, guidance etc. are communicated for inclusion into the Global Pharmaceutical Quality System
- Lead information regarding external regulations and trends globally for input and feedback with SME's throughout the Pharma Tech organization
- Advise key stakeholders at global and site level on best practices, key opportunities and threats in the areas of Quality and Compliance. Participate in the PTQE Compliance opinion process
- Establish and evolve External Relations programs, processes and activities to expand awareness and impact across Roche
Who you are?
You like working in a diverse environment and you are demonstrating flexibility, agility and initiative. To be successful in this role we believe you need:
- Bachelors or Advanced degree in Pharmaceutical technologies with 10 or more years related professional experience and deep understanding of regulatory, quality or process development
- Experience with manufacturing, analytical, compliance and regulatory issues including knowledge of Quality Systems. Knowledge of ATMPs and Emerging Technologies a plus.
- Deep experience in interaction with, or collaborating with Global Regulatory agencies on topics of GMP and Quality. Demonstrated success in leadership roles in applying regulatory requirements and quality systems to the manufacture of pharmaceuticals through various lifecycle stages
- Proven ability to establish credibility with key stakeholders as a trusted though leader
- Experience in interacting with industry and professional organizations in Manufacturing and Quality areas and high energy to participate or lead workgroups and give presentations
- Ability to travel domestically and internationally
Qualified candidates are encouraged to apply by: June 4, 2020
This position is not car eligible.
This position is not eligible for relocation support.
This position is open to applicants legally authorized to work in Canada.
Roche is an equal opportunity employer and prohibits unlawful discrimination based upon any legally protected ground. Roche will make a good faith effort to accommodate the individual needs of applicants with disabilities in our recruitment process.
NOTE: All employment is conditional upon completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.
Roche is an equal opportunity employer.Audit & Compliance, Audit & Compliance > General Compliance