Shire Associate Director Quality Validation in Lexington, Massachusetts

Primary Role:

This position is responsible for all or multiple segments of the validation function at a location. Responsible for managing, developing and implementing validation processes to ensure products meet with appropriate regulatory agency validation requirements, internal company standards and current industry practices. Oversees and reviews validation area processes and procedures, making recommendations for changes and/or improvements. Position may focus on equipment, process or control system validation or a combination there of.

Responsibilities:

Job Function and Description

  • Incumbent will schedule, plan and manage validation projects including: new facility planning and constructions, equipment selections, acquisition, installation and use; facility/system/process improvements, modifications and additions; computer-based systems and software.

  • Responsibilities also include oversight for the development, completion, logging and archiving of documentation on protocols, Validation Master Plans, and Validation Summary Packages.

  • Responsibilities may also include directing or participating in: performing technical failure analysis of processes/product not meeting specifications, developing statistical process control programs to monitor processes, reporting on trends to reduce product/process variability.

  • Applies statistical analysis and design of experimental approaches to process development activities.

  • Develops and administers budgets, schedules and performance requirements.

  • Coordinates activities of personnel in other departments and contractors as well as providing day to day guidance to the Validation staff. Acts as advisor to subordinates to meet schedules and/or resolve technical problems.

Education and Experience Requirements

Requires bachelor's degree, preferably in science, engineering or other related technical field. 8+ years of related experience with 3+ in a management role.

Key Skills, Abilities, and Competencies

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. Also, must be able to identify subtle discrepancies in processes or products and have good judgment in determining impact and potential risk.

  • Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.

  • Proficient in Microsoft Word and Excel, computer software.

  • Sound industry knowledge, project proficiency, and autonomy expected.May be considered a Subject Matter Expert (SME) in various disciplines.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire is 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 call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.