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Global Validation HeadPosted by: Alcon
Posted date: Jul-28-2015
Location: Fort Worth, TX
The position will be based in our Ft. Worth, TX location. Relocation assistance will be provided.
This is an excellent career-growth opportunity for a highly experienced Validation professional (Senior Lead, Manager or Associate Director level and above) experienced in leading innovative validtaion processes working within a matrixed organization.
Develops, implements and manages divisional process validation, packaging validation, cleaning validation and revalidation strategies to meet cGMP requirements on time, on budget and quality to ensure that programs are compliant with inspection agencies’ requirements and related SOPs. Validation Master Plan: Establish/maintain a high level overview of state of validation across the division. Establish the project prioritization across sites. Partner with Quality based on feedback (e.g. via regulatory inspections, changes in regulations) to establish common approach and translate that for the sites. Partner with Engineering to define the process validation/ equipment qualification interface. Establish an escalation process to address difficult validation and technical challenges. Support link with Development to be able to tap into knowledge repository (e.g. for late life cycle products). Maintains all activities in an inspection ready status ahead of any internal or external audits to ensure successful inspections e.g. no critical observations related to validation activities. Active participation in driving the development/application of a consistent training approach for validation across the division.
Validation activities: Provide guidance and governance on approach, drive harmonization/standards across the division. Ensure the right validation capabilities are in place across the division to support technical transfers. Facilitate/coordinate global validation projects; provide support in resourcing capital investment projects for validation activities. Represent the division in all x-divisional activities relevant to validation (e.g. harmonization of standards). Ensure proper interaction between API drug substance, drug product, and/or device sides e.g. for risk assessment, critical variables, liaising effectively within internal and external functions. Be a senior advisor in case of difficult validation challenges. Will not be a signatory on validation protocols however need to facilitate any related knowledge transfer. Ensure that all respective validation activities are performed and are in line with the current Novartis requirements and cGMP, handling any deviations associated to these activities including oversight of pre- validation and validation resulting from major or complex changes. Benchmarks against internal Novartis and external industry standards with the aim of achieving best-in-class standards and practices, expands and shares knowledge throughout the network. Develop budget for validation activities at divisional level. Support developing high performing teams at site level.
Relocation Assisatnce is provided.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. Alcon participates in E-Verify and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. The Novartis Group of Companies are also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to alcon.recruitmentalcon.com and let us know the nature of your request and your contact information.
Relocation assistance will be provided if required.
Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology. Desirable would be a Master's Degree and above or equivalent. Fluent in English. Desirable German or French or Italian. 10 years’ experience in manufacturing/ manufacturing science and technology/technical development/Quality. Thorough understanding of product processes. Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities. Fundamental understanding of standard pharmaceutical analytical testing. Expert in reviewing and writing technical reports.