Shire Quality Validation Manager in Neuchatel (Baxalta), Switzerland
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, Ophthalmic, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology. In 2016, Shire grew its organization to approximately 24,000 employees+ globally, following integrations of Dyax and Baxalta.
An exciting and challenging opportunity has become available at Shire Neuchâtel Plant (approx. 650 employees) for a global role for Quality Validation manager
This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile professional to embrace a team-based culture and more specifically within the quality and engineering validation teams within a world-class Biotech manufacturing environment
Responsible to review and approve validation protocols, reports, procedures and other related documents to ensure compliance to internal procedures and regulatory requirements.
Evaluate and approve deviations related to validation protocols in order to guarantee proper tracking/ documentation of the incidents and identification of corrective actions.
Collaborate and participate in projects as a Quality Representative for Validation. Provide validation expertise and support for the development (or modification phases) of manufacturing facility, equipment/systems, Cleaning, Sterilization, material Qualification (on demand), process validation and Automated System and Computerized System.
Approve & support the definition of the process development strategies and ensure linkage with PPQ strategy deployment
Participate and approve PFMEA & RACT and other risk assessment supportive to validation strategy
Participate in internal and external audits
Participate in the evaluation of Change Control requests and provide support in the review of the associated risk assessment
Support process deviation evaluation in regards to validation impact
Ensure that the information contained in approved validation document(s) is understandable and defendable during inspection.
Manage the validation maintenance activities (Responsible with Site Engineering of the re-validation program.
Ensure approval in a timely manner of the re-qualification / re-validation.)
Approve the Master Validation Plan., Validation plan associated to project implementation.
Participate in multi-site initiatives to ensure harmonization of validation activities between the plants
Manages coaching, training and development for the team Manage and monitor budget
Experience in Pharmaceutical Production
Experience in internal and external audit
Hands-on experience in the validation area
At least 5 years of resources management experience
Good verbal and written communication
Ability to interact with all types of personalities in an effective and diplomatic manner.
Critical thinking and demonstrated problem solving / root cause investigation skills.
Good technical knowledge/ understanding
Deep knowledge of regulations and a thorough understanding of ICH guidelines and the various validation guides such as PDA Technical guides, ISPE GAMP guides etc,
Good English speaking skills
Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:
Be Results Oriented
Be An Excellent Manager of Self and Others
Notice to Employment / Recruitment Agents:
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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.