Principal Quality Specialist
Closing Date: 04 Dec 16
Type: Full Time
Salary (£): On Application
Implement the controlled document strategy for PDQ and the supported business partners (gRED, pRED, PD, GPS and affiliates) for all relevant regulatory compliance standards and processes related to clinical development and safety/pharmacovigilance.
To develop Standards, Policies and SOPs, from identification of needs, to execution of development and deployment of outputs and materials.Primary Responsibilities and Accountabilities:. ...
- Implement the controlled document strategy for PDQ and the supported business partners (gRED, pRED, PD, GPS and affiliates) for all relevant regulatory compliance standards and processes related to clinical development and safety/pharmacovigilance.
- To develop Standards, Policies and SOPs, from identification of needs, to execution of development and deployment of outputs and materials.
Primary Responsibilities and Accountabilities:.
- Independent development of GxP Standards; Policies & SOP throughout all of the Roche development related organizational enterprises (gRED, pRED, PD, GPS and affiliates) to ensure a consistent documents landscape for standards and processes related to clinical development and safety/pharmacovigilance which meet internal and external standards versus regulatory and compliance related regulations and interpretations.
- Establishes, maintains and fosters strong relationships with key business stakeholders and ensures that PDQ is providing an efficient, effective and compliant process landscape to the functions.
- In close collaboration with supported functional areas and key business stakeholders, proactively identifies needs for process standardization, regulatory compliance direction and areas for improvement.
- Ensures that business partner expectations for SOP strategy, materials and deployment are met.
- Ensures in collaboration with business partners that Policies and SOPs in the controlled document landscape are up-to-date and regulatory compliant versus current Clinical and safety/pharmacovigilance international regulations.
- Collaborates with a network of subject matter experts (SMEs) within the functional areas supporting policy and SOP development.
- Contributes to the PDQ Standards & Processes Team to set strategies and achieve the long-term goals & objectives for PDQ QS and PDQ as a whole.
- Is knowledgeable of all services and activities provided by PDQ QS, Standards &Processes in order to provide business stakeholders with a comprehensive overview and effectively communicates how their training needs can be met.
- Functions as trainer for Quality Specialists and provides mentoring in collaboration with the Head of Standards & Processes Governance
Who you are
In hiring new employees, we look for people who are also inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. Because we know that employees are critical to our success in bringing novel medicines to patients, we are dedicated to remaining a great place to work and to providing employees with programs, services and benefits that allow them to bring the best to the business and to their personal lives.
- University degree in Science-related subject or other related field. Advanced degree preferred.
- >7 years in the pharmaceutical industry, preferably development and working in a GxP regulated area; broad understanding of global expectations of Health Authorities in the area of Pharma Development.
- Experience in preparation, development and administration of GxP standards and processes.
- Considerable organizational awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams.
- Demonstrated knowledge of GCP, Pharmacovigilance/drug safety and regulatory requirements, as well as analytical, organizational and planning skills.
- Substantial knowledge of all services and activities provided by PDQ QS, Change Management expertise.
Experience, Skills, Knowledge:
- Solid knowledge of GCP, PV and regulatory requirements.
- Strong interpersonal and stakeholder management skills, including a customer focused approach, and highly effective teamwork and collaboration skills.
- Ability to build and maintain good relationships with key business partners.
- Skills for problem identification / resolution in a complex environment or potential conflict.
- Ability to analyze and simplify complex systems or processes into pragmatic solutions.
- Effective communication and influencing skills and leading without authority.
- Can successfully manage cross-functional and interdisciplinary teams and projects.
- Ability to work effectively in an international multicultural matrix organization.
- Fluency in written and spoken English.
Highly Weighted Competencies: Focus on value and customer, align for success, deliver results in-time, proactive approach, creative in solution development, and strong communicator
Other (e.g. Travel): International travel as required
Who we are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.