OBJECTIVES: (Briefly summarize the overall purpose of the position. Objectives should
be written in 3 – 4 bulleted statements).
Provide Site Validation Program strategic leadership to ensure the programs are aligned with regulatory agency expectations, Takeda Global Standards and industry best practices. Additionally, this position will network with Takeda Validation Leads across the network to ensure effective and efficient sharing of best practices.
Responsible for developing, implementing and managing the validation program which includes; Process, Cleaning, Computer System, Sterilization, Shipping, and Equipment in accordance with regulatory agency requirements,
Lead and influence effectively to ensure all necessary Commissioning, Qualification and Validation (CQV) activities are completed on time, within budget and according to the validation program.
Act as primary liaison for site validation and participate as required in regulatory inspections.
ACCOUNTABILITIES: (Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 – 10 bulleted task statements should be identified).
Manage the site validation program and activities for manufacturing equipment, utilities and facilities qualification, shipping, computerized systems validation, cleaning validation, and process validation.
Continually assess current validation program against regulatory inspection findings, emerging practices. Identify validation program improvements and develop the necessary action plan to ensure a continuous state of compliance.
Develop CQV programs and procedures aligned with regulatory requirements and effectively communicate the validation approach to peers, management, and regulatory authorities as required.
Schedule, plan and manage CQV projects including oversight for the development, completion, logging and archiving of CQV documentation.
Responsible for managing and tracking execution of validation activities versus project timelines. Manage and plan the work of the department and contract resources. Assessing workload and managing resource deployment to achieve departmental goals.
Coordinate validation projects with in-house personnel (within department and/or cross functional reams) and contractors.
Act as advisor to subordinates to meet schedules and/or resolve technical problems.
Coach and mentor staff in all aspect of their job performance and career development including training, feedback, rewards and disciplinary action.
Provide input into the department budget. Establish and report applicable department metrics that drive accountability.
Complete mandatory training within required timeframe.
Perform other duties as assigned.
SCOPE OF SUPERVISION:
NUMBER SUPERVISED WORKERS
Up to 15+
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)
Preferred combination of education and experience:
Master’s degree or PhD in engineering or other scientific/technical discipline with 7 years of relevant experience; or
Bachelor’s degree in Engineering or other scientific/technical discipline with 12 years of experience; or
10-12 years of relevant experience within the pharmaceutical, biotechnology or biopharmaceutical industry highly desirable
3-5 years’ experience in managing employees and contract resources preferred.
Competencies and skills:
Working knowledge of cGMP guidelines, FDA 21 CFR Part 11, 210/211, 820 regulations, ICH guidelines and other international regulatory requirements.
Sound industry knowledge, project proficiency, and autonomy expected.
Demonstrates initiative; ability to undertake additional responsibilities and respond to situations as they arise with little or no supervision.
Requires excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel.
Ability 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.
PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the primary responsibilities of the position).
In general, the position requires a combination of sedentary work and walking around the facility.
May occasionally lift up to 25 pounds
May be required to occasionally wear personal protective equipment (PPE) and other clean room garments when working in certain areas of the facility and/or while working around chemicals such as acids, caustics, buffers and bleach. The PPE may include: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection
May be required to travel occasionally
ADDITIONAL US SPECIFIC INFORMATION (FOR US RECRUITMENT ONLY): E.g. Number of years of experience, ADA
ADDITIONAL EUROPE SPECIFIC INFORMATION (FOR EUROPEAN RECRUITMENT ONLY): This section should reiterate minimum/essential requirements for role