ESSENTIAL RESPONSIBILITIES :
Direct the Validation Program
Develop, implement and maintain the site Validation Program to bring and sustain the company’s systems and policies into compliance with ISO13485 and relevant 3rd party validation requirements.
Manage the site validation program and activities for manufacturing and testing equipment, utilities and facilities qualification, computerized systems validation, shipping validation, cleaning validation, test method validation, scale-
up / product technical transfers, and process validation.
Identify validation gaps, develop and implements Validation plans to ensure a state of compliance is maintained using a risk-based approach.
Identify and manage continuous improvement efforts with the objective to achieve quality, reliability and cost improvements.
Manage and track the execution of validation activities versus the validation plan and / or project timelines to meet company goals.
Track and report metrics related to validation / qualification activities.
Manage, coordinate, and plan the work of the department and contract resources. Assess workload and managing departmental / cross-
functional resources to achieve departmental goals and validation projects.
Schedule, plan, and manage Validation activities / projects including management of the development, completion, logging, and archiving of Validation documentation.
Writing and review of procedures and policies required for the validation program.
Develop Validation procedures that interpret and apply regulatory (where applicable) requirements concerning validation activities and present the validation approach to peers, management, and regulatory authorities as required.
Observe and evaluate processes to make appropriate decisions on issues relating to the validation program adherence and improvement.
Act as an advisor to direct reports and customers / stakeholders to meet schedules and / or resolve technical problems.
Ensure the Qualification / Validation programs are technically sound.
Ensure that the Master Validation Plan and Site Validation Plan are up to date.
Ensure that progress against the Validation Plan is visible to the business.
Support the maintenance and Calibration programs
Validation budget control.
Obtain quotes for Validation related costs from Suppliers and negotiate pricing.
Provide input into the department budget. Establish and report applicable department metrics that drive accountability.
A good understanding of resource allocation and forecasting
Communicate the status of the validation program to the company and relevant 3rd parties.
Communicate with departments with validation planning
Communicate any validation related delays / issues / changes to customers, stakeholders, senior leaders, etc.
Ensure that adequate technical training is provided to the validation team and business on all Validation related procedures and requirements in order to foster high-performance teams.
Review validation related protocols and procedures written by the validation team members and / or departmental staff.
Primary liaison for site validation and participate as required in regulatory and / or customer inspections.
Active involvement in CR / NCR / CAPA / RCA process investigations related to qualification and validation.
Ensure that any changes to the business that may impact Validation are risk assessed and, if implemented, tracked for additional Validation actions to take place following implementation.
Establish, nurture and maintain good working relationships with internal and external customer / stakeholders through regular communication, networking and attending relevant meetings.
Partner with the Roche validation network to strengthen the Validation program and to foster the exchange of ideas and best practices.
Team Culture and Performance
Build a team culture of excellence, exceptional work ethic, the superior quality of work and collaborative team spirit.
Coach, mentor and provide direction to the team in all aspect of their job performance and career development including training, feedback, rewards and remedial action
Recommending appropriate measures to address continuous improvement opportunities.
MINIMUM QUALIFICATIONS :
Formal Training / Education :
Masters in Engineering or Scientific discipline;
Certificate in a scientific discipline and a minimum of 10 years’ experience within validation preferred
Minimum of 8 years in a similar role; 10 years preferred in a similar role
Knowledge, Skills, and Abilities :
Working knowledge Diagnostics and / or Pharma would be preferred
Working knowledge of ISO Quality Management systems and Diagnostics would be preferred
Highly self-motivated, have excellent organization and able to communicate effectively at all levels in verbal and written form, including technical / business writing.
Able to establish and manage multiple cross-functional teams simultaneously.
Willing and able to work independently and as part of a multi-disciplinary team.
Comfortable with change and be willing to establish and work towards the future vision of the organization
Personal Skills : Drive to achieve, Attention to detail Initiative, Planning & Organizing, Adaptable, Effective time management, Assertive.
Interpersonal Skills : Critical Thinking, Team player, Communication, Motivating, Flexible, Coaching.
Managerial Skills : Mentoring & Coaching, Agility, Accountability, Strategic Thinking, Decision making, Change management, Prioritization, Resource Allocation, Development, Sense of Urgency.
TRAVEL REQUIREMENTS :
Possibly up to 5% of International Travel.
Who we are At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-
focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer.