Associate Director, Validation

11 - 15 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 09/22/17
Waltham, MA
11 - 15 years experience
Biotech/Pharma
Salary depends on experience
Posted on 09/22/17

 

POSITION SUMMARY

The Associate Director of Validation is based in Waltham, MA and reports directly to the Senior Director of Validation. The holder of this position is responsible for leading the validation effort for Computerized Systems and/or oversight of validation activities at Contract Manufacturing Organizations (CMOs).  The successful applicant will be a subject matter expert of validation of Computerized Systems and Processes and play a lead role within Project teams representing Validation.

 

KEY RESPONSIBILITIES

  • Determine levels of importance or risk to be assigned to elements under review to ensure validation efforts are directed at the systems which have the potential to impact product quality, efficacy, and data integrity using a variety of tools including GAMP 5 and Quality Risk Management.

  • Development and execution of Validation related documents throughout the system lifecycle.

  • Present a coherent and clear picture of validation effort to any reviewer or auditor, providing confidence in the installed system, process, facility or procedure.

  • Understand the science and areas of technical knowledge that underpin area of focus and must be able to apply this knowledge in the development of validation approach and in the presentation, documentation/recording & review of outcome

  • Represent the validation group in forums such as audits, KPI reviews and associated issue resolutions.

  •  Understand best industry practice, current developments and opportunities arising for Alkermes.

  • Collaborate with internal and external Customers to explain how the validation approach in Alkermes provides both assurance of compliance and adequacy of transferred process and is effective and efficient (time & cost)

  • Actively participate in Professional/Industry groups to learn, influence and represent Alkermes.

  • Contribute in areas such as change control, investigations, APR’s, and PR’s, VMP’s and SOP updates.

  • Contribute to updates to Validation systems (policies, procedures, reviews, VMPs, etc.) ensuring they meet current / changing industry best practice demands and that they do so effectively. 

  • Responsible for the maintenance of validation systems and ensure compliance of Validation corrective actions.

REQUIREMENTS

  • Degree in a Computer Science, Information Systems, Process Automation, Science or other related field with 10+ years relevant experience.

  • Must be familiar with Regulatory requirements and guidance applicable in area(s) of deployment.

  • Areas of expertise include validation of cGMP Computerized systems / Process Automation Control Systems/Process validation within an FDA /EU and rest of world regulated environments.

  • Comprehensive knowledge of Validation lifecycles for Computerised Systems and Process Control Systems  and ideally process manufacturing systems

  • Experience in Validation of Computerised Systems/Process Automation Control Systems such as Werum PAS-X MES, SAP, scientific data management systems such as LIMS, electronic notebooks and Empower, SaaS (Software as a Service) systems, Trackwise, Rockwell Process Control Systems, is desirable.

  • Excellent written and verbal communications, including technical writing. Microsoft Office Software, with MS Project.

  • Knowledge of statistics and their application to such aspects as process sampling and data trends analysis

  • Experience in the biotechnology and/or pharmaceutical industries

  • Practical experience with quality risk management and risk based validation approaches.

  • Thorough understanding of industry standards and best practices computer system validation such as GAMP 5 and ASTM E2500, and data integrity requirements

  • Knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10.

  • Demonstrated Project Management abilities to lead and manage a high volume of simultaneous projects.

  • Confident and comfortable working with cross functional or cross site teams to root cause issues and reach collaborative solutions

  • High level of technical aptitude with demonstrated initiative and attention to detail

  • Willingness to travel to other sites, CMOs or vendor audits as required

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