Team Leader Standards & Process Governance, Quality Services
Closing Date: 28 Oct 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.
- Lead the team of SOP Managers and SOP Specialists
- Provides line management support for direct reports and consistently capitalizes on opportunities to recognize or coach each individual to higher performance.
- Provide leadership and line management to the team across multiple locations
- Ensure that the performance of employees is proactively managed and they are coached,
- trained and developed in order to maximize their contribution.
- Ensure that staff communication and employee relations are managed proactively to maximize the wellbeing of the employees.
- Actively install the Roche values in the team and their activities.
- Identify future resource needs and identify, recruit, train and develop appropriate talent.
- 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 via the Standards & Governance team 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.
- 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 SOP Managers and Quality Specialists-Standards and provides mentoring in collaboration with the Head of Standards & Processes Governance
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.Education/Qualifications:
- 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.
Experience, Skills, Knowledge:
- Substantial knowledge of all services and activities provided by PDQ QS, Change Management expertise.
- 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 analyse and simplify complex systems or processes into pragmatic solutions.
- Experience, Skills, Knowledge (cont.):
- Effective communication and influencing skills and leading with and 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.
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.