Head of Quality Technical Services

Roche Singapore Technical Operations Pte Ltd

Head of Quality Technical Services

Roche Singapore Technical Operations Pte Ltd


Position Level: Experienced, Manager

Qualification: Bachelor's / Honours, Masters / PhD

Job Nature: Permanent


Purpose

  • Responsible for managing the lifecycle of physical and electronic GMP records (from the point of creation at the project level through their ultimate archival and retirement).
  • Provide Quality oversight in the review and approval process of documents to ensure documentation is released on time. 
  • Provide Quality oversight on approval and managing physical and electronic GMP records/documentation to meet PQS and HA requirements

Key Responsibilities
 
Technical and Functional:
  • Ensure the EM and clean utility control strategies are robust and compliant in accordance with Roche site and PQS requirements.
  • Review and approval of site EM and clean utility trend reports.
  • Partner with Roche site cross-functional groups and global teams to drive improvements to the facility environment with a goal to reduce EM, clean utility and equipment excursions and adverse trends.
  • Own and manage facility and utility related DMS and lead EM and clean utility DMS RCA activities.
  • Provide QA oversight for QC labs, site media fill program and tank management program (as applicable by site).
  • Ensure programs/documents that Technical Services has oversight of supports a continuously compliant state at the assigned PT Site and a continual state of readiness for regulatory agency inspections.
  • Support regulatory inspections and partner audits.

Leadership and People Management:
  • Lead and manage all aspects of people processes - organization, staffing, talent management, performance management to meet strategic and operational objectives.  Direct staff in setting operational objectives and business goals for their respective areas of responsibility.
  • Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term.  Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
  • As a leader within the Quality Assurance Operations team, drive network activities and alignment, cross-functional planning, and decision making.
  • Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements.
  • Embody PT lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.

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.

Qualifications

Education:
  • At least a Bachelor's Degree in a relevant science discipline

Experience:
  • 5 or more years’ work experience in the pharmaceutical or related industry
  • 2 or more years’ people management experience would be preferred

 Knowledge/Skills/Competencies:
  • Strong knowledge in document control and archival duties associated with electronic document management solutions, databases and spreadsheets. 
  • Strong knowledge in cGMP requirements regarding documentation lifecycle management.
  • Demonstrated expertise in Microsoft Office programs (Word, Excel, Outlook, PowerPoint, Visio).
  • Able to prioritize tasks in order to carry out activities related to document management
  • Able to make strategic and sound decisions on quality matters
  • Demonstrated excellent organizational and planning skills in implementing systems or projects
  • Good interpersonal, oral and written communication skills in English

Appointment to this position will be on local Singapore salary and benefits package.



Company Overview

Roche Singapore Technical Operations

Roche Singapore Technical Operations is Roche’s first biologics manufacturing site within Asia region, and the first company in Singapore to produce US FDA licensed bio therapeutics using recombinant DNA technologies. 

Our Vision and Mission


We will be the most admired biotechnology production operation, respected for our world class innovation, engrained quality inspired people and operational excellence.
Quality is every patient’s right and every employee’s responsibility. Quality provides a competitive advantage and is engrained in everything we do, from concept through continuous improvement. Because Roche’s products touch human lives, quality is the true measure of our success.
The Business of Improving Human Lives
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