This position can be located in Lexington, MA or Exton, PA.
This position will be part of the CMO Quality group responsible for representing Shire's Quality function during qualification and validation activities related to cold chain/controlled temperature shipments and CMO drug substance & product manufacturing / packaging operations and will involve;
- Working with the cross functional teams in the development, execution and approval of CMO validation activities associated with new equipment / product or system upgrades.
- Supporting the strategy for Shire generated documents (e.g. specifications, plans, protocols, procedures) to support cold chain / controlled temperature transportation and new process/product introductions to support supply continuity and process improvement requirements
- Managing QA oversight through the provision of compliance and technical input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project.
- Providing final Quality agreement and approval for CMO related documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls)
- Overseeing the resolution of deviations initiated during qualification / validation execution at the CMO facilities and ensuring escalation to other Shire Quality groups as appropriate.
- Responsible for the co-ordination of External Quality activities associated with Tech Transfers, Process Validations and facility/equipment projects, and ensuring the other Quality groups (QA Disposition, Quality Operations, etc.) are informed / present as appropriate.
- Ensure adherence to the Shire change control process, review change controls for QA Validation impact, promotes timely approval of all supporting documentation.
- Generation / approval of SOP's / other governance documentation as applicable.
- Co-ordinate qualification activities with contractors and vendors as required.
- Manage a continuous professional development plan to fulfil the role of QA Validation Engineer.
- Supporting the CMO Quality Lead in the development of training material for CMO Quality Team.
- Domestic and international travel may be required (15%).
Provide QA oversight to cold chain qualifications, CMO Drug Substance / Product process validation, equipment, packaging and labeling qualifications for Shire per defined policies and procedures.
Define strategies for external validation efforts, including development of master plans/ project plans etc. Manage and coordinate the review / approval of validation protocols, data analysis, and development of final reports. Schedule and lead meetings with CMOs, external manufacturing, regulatory affairs, PDTS and other personnel to gain consensus on protocol content, protocol execution, and resolution to failures to meet protocol requirements.
Assess quality systems including deviations, CAPAs, change controls, investigations etc. for validation impact.
Support authoring and review of CMC sections of filings related to external validation activities and response to questions from agencies as needed.
Support continuous improvement activities related to validation, quality, and compliance.
Education & Experience Requirements:
- Minimum relevant 3rd Level Qualification, B.Sc. in chemical/biochemical engineering or related field with validation experience in the biotech/pharma industry is required
- Minimum of 4 years direct experience in a validation role in either the Medical Device or Pharmaceutical/biopharmaceutical industry.
- Strong knowledge of CSV/GAMP, 21CFR Part 11, Annex 11, Project Life Cycle and quality systems, cGMPs, GDPs and FDA/EMEA guidelines and proven ability to apply guidelines to all aspects of qualification activities.
- Experience with Aseptic/Sterile Manufacturing and /or Qualification experience in a project environment within the pharmaceutical or biopharmaceutical industries and/or cold chain qualifications is preferred
- Experience dealing with contract manufacturing organizations is preferred.
- Must be comfortable and flexible with ambiguity in a "start up" environment, able to prioritize and multitask in a environment with changing priorities
- Firm sense of accountability, ownership for end-to-end project lifecycle and sound knowledge of project management.
- Good knowledge of statistical techniques in the use of problem solving / data analysis.
- Solid verbal and written communication and presenting skills with the ability to interact with technical and non-technical groups.
- Adaptable and flexible
- Ability to demonstrate standards of leadership - managing complexity/ Innovations / Customer Focus Flexible Team Player Good influencing skills
- Demonstrated experience in validation protocol development, execution and reporting is required.
- Experience in managing complex validation projects in a fast paced environment is required.
- Experience of Technology Transfer, Process Scale up and process improvement projects preferable.
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.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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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.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.