Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Pharmiweb.com RSS Feed PharmiWeb Candidate Blog

Pharmiweb.com RSS Feed PharmiWeb Client Blog

Job Details

PDQS Head, Associate Director- Standards Process and Governance

Company: Roche
Location:
Reference: 3239413341
Closing Date: 11 Dec 16
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

> Job Purpose:   Locations: Can be located in any of these locations: SSF (US) or Basel (CH) or Welwyn (UK) Owns and deploys the Roche controlled document and training strategy for the business (gRED, pRED, PD and affiliates) for all relevant regulatory compliance processes, procedures and training related to clinical development and safety/pharmacovigilance (GCP and GVPs) (respective to designated discipline Process and Procedures or Learning Solutions)D ...

Requirements:

>

Job Purpose:

 

Locations: Can be located in any of these locations: SSF (US) or Basel (CH) or Welwyn (UK)

  • Owns and deploys the Roche controlled document and training strategy for the business (gRED, pRED, PD and affiliates) for all relevant regulatory compliance processes, procedures and training related to clinical development and safety/pharmacovigilance (GCP and GVPs) (respective to designated discipline Process and Procedures or Learning Solutions)
  • Drives standards and quality in the development of controlled documents and learning solutions from identification of needs, definition of the associated process-specific business ownership (=Global process owners), cross-functional alignment and decision making
  • Oversees the global operating system (condor) for management of Controlled Documents and the global learning management systems (s) for training.
  • Oversees process compliance and owns compliance metrics related to controlled documents and training within the Roche global QMS for reporting global compliance bodies (CMO Office, Medical Compliance Committee (MCC)
  • To lead a team of managers and senior level individual contributors in PDQS

Primary Responsibilities and Accountabilities:

  • Accountable for Standards, System & SOP governance 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 which meet internal and external global GCP/GVP standards
  • Accountable for developing the procedural document strategy and its communication to senior management, in the Roche global Process & Procedures Committee (PPC), in global Health authority inspections and in other global compliance activities
  • Operates globally and cross-functionally with a high degree of autonomy and is accountable for establishing, maintaining and fostering strong relationships with management and key business stakeholders, such as Heads of compliance & Quality, Global Process Owners, and Functional Excellence heads, to drive proactive identification of areas for improvement, cross-functional alignment, decision-making authority and execution of the strategy.
  • Leads the team to support the successful and timely development and rollout according to the end-to-end service model of processes required as part of the global Quality Management System (QMS).This includes prioritization and assignment of tasks with several external stakeholders across PD and gRED/pRED, such as Global Process owners and MCC sponsors (CMO and PDLT), Functional Excellence (FE), and Functional Quality responsibles (FQRs), as well as the CMO Office, QLT and across PDQS teams. Ensures full alignment of document development and training development and deployment schedule. Accountable to ensure documents are compiled and issued on time and periodic status updates are prepared and reported.
  • Ensures in collaboration with GPOs and respective Committees (PPC, GCP and GVP council,) that Policies and SOPs and training in the controlled document and training landscape are up-to-date and compliant and reflect the Roche compliance strategy
  • Oversees the implementation and management of innovative IT tools and User Interface solutions required to support the maintenance and usability of the controlled documents and training in a compliant and efficient manner.
  • Builds and actively leverages a network of global subject matter experts (SMEs) within the functional areas supporting policy and SOP development and training.
  • Participates as a member of the PDQ Quality Services Leadership 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 and PDQ in order to provide business stakeholders with a comprehensive overview and effectively communicates how their training needs can be met.
Support and implements the PDQS operational strategy for effective operations and efficiency,

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.
  • >10 years in the pharmaceutical industry, preferably development and working in a GxP regulated area or associated discipline (controlled document management and/or Learning); broad understanding of global expectations of Health Authorities in the area of pharmaceutical development.
  • Experience in preparation, development and administration of controlled documents, training programs and systems Demonstrated leadership in implementing robust quality systems in a regulated area.
  • Experience including oversight and administration of validated electronic systems such as ConDor,other document management systems, learning management systems and tools.
  • Considerable organizational awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams.
Minimum:
  • Knowledge of GCP, Pharmacovigilance/drug safety and regulatory requirements, as well as analytical, organizational and planning skills.
Desired:
  • Substantial knowledge of all services and activities provided by PDQ, QS.
Experience, Skills, Knowledge:
  • Solid knowledge of GCP, PV, regulatory requirements and Quality Management Systems.
  • In depth experience in preparation, development and administration of complex training programs (utilizing multiple modalities), curricula, systems and processes.
  • Excellent interpersonal and stakeholder management skills, customer focused approach, and highly effective teamwork and collaboration skills.
  • Ability to build and maintain strong relationships with key business partners.
  • Demonstrated a successful record of problem resolution in an extremely complex environment or significant conflict.
  • High decision-quality and ability to analyse and simplify complex systems Demonstrated ability to effectively communicate, influence and lead both with and without formal authority
  • Demonstrated ability to effectively communicate, influence and lead both with and without formal authority.
  • Proven strong track record to successfully manage large cross-functional and interdisciplinary teams and large projects.
  • Ability to work effectively in an international multicultural matrix organization.
  • Demonstrates ability to solicit and merge global and multi-functional perspective.
  • Excellent written and spoken English
*LI-gRED-HB

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.

Apply for this job: PDQS Head, Associate Director- Standards Process and Governance

Contact Information:

Address:  UK Head Office
P.O. Box 8, Welwyn Garden City, Hertfordshire, United Kingdom
AL7 3AY
England
Tel:  +44 1707 36 6000
Fax:  +44 1707 33 8297
Website:  Visit Our Web Site

Advertising
Share | | |
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.