The role is accountable for disposition activities with the QA Disposition group supporting Lex Site including satellite sites.
The scope of operations includes raw materials, cell bank (CB), unpurified bulk (UPB) and drug substance (DS) disposition activities performed in support of manufacturing activities executed Lex Site within the Biologics Operating Unit.
This position will be responsible for the timely disposition of raw materials, CB, UPB and DS in line with global regulatory expectations and Shire standards.
This position will be responsible for working with cross functional groups in each department supporting manufacturing operations within the Lex Site organization. This position is responsible for ensuring consistency and communication, where appropriate, across the manufacturing operating sites.
This individual will partner closely with other QA groups, QC, Manufacturing, Compliance, Materials Management, Regulatory and Supply Chain to ensure timely disposition of raw materials and products.
Strong collaboration and the ability to effectively work with cross functional groups are critical to success.
Direct responsibilities include:
Disposition Activities (60%)
• Responsible for review of all criteria required for disposition of raw materials and products
• Responsible for review of investigations and quality systems related to disposition of specific batches
• Responsible for SAP transactions relevant to disposition
• Responsible for collaborating with key stakeholders including but not limited to Supply Planning, Materials Management and Supplier Quality relative to raw material quality concerns and batch disposition planning
• Accountable for meeting functional area goals and objectives as they relate to disposition activities
Quality System Activities (10%)
• Responsible for preparing post release notifications and quality alerts as required
• Responsible for preparing quality disposition memos as required
• Responsible for reviewing Material Review Board presentations
• Responsible for representing quality on complex investigations and multi-disciplinary teams as required
Site Metrics (15%)
• Responsible for metrics around disposition
• Group metrics' tracking and compliance
• Responsible for presenting disposition metrics in various forums
Inspection Support Activities (5%)
• Support regulatory submissions and inspections
Continuous Improvement Activities (10%)
• Responsible for continuous improvement on an ongoing basis to proactively mitigate current and future risks to maintain an effective operation to support business needs in a compliant manner.
Education & Experience Requirements:
• BS with 5+ years relevant Quality experience
• Quality experience must include disposition processes and complex decision making
• Strong relevant experience in executing, developing, and/or administrating GMP programs in cGMP biotech and/or pharmaceutical environments.
• A minimum of 5 years in a cGMP biotech and/or pharmaceutical environment plus a minimum of 3 years specific to disposition of UPB and DS.
• Significant experience in review of quality system and disposition requirements
• Excellent interpersonal skills and the ability to communicate well orally and in writing.
• Strong business acumen (Operations, productivity, continuous improvements)
• Experience interfacing with regulatory bodies
• High level of professional competence.
Other Job Requirements:
Local travel between plants and warehouses within Lex Site including satellite locations.
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.