Shire Manager - Quality Lab in Milford, Massachusetts
The Quality Control Manager will lead and oversee the Milford site’s Microbiology laboratory to ensure product safety and reliability, assuring that all quality and regulatory requirements are met. The QC Manager represents the Microbiology function by working closely with Manufacturing and Product Development teams to ensure schedule adherence and product safety.
Direct supervision of Microbiology lab team members including establishing employee goals and objectives, assessing performance and providing regular feedback, coaching and developing employees. Also ensure that department team is properly trained and remain in compliance with training requirements at all times.
Ensure compliance with testing SOPs and specifications. In compliance with GDP, prepare, review and revise SOPs and specifications. Write memos, reports, protocols, and other appropriate documentation for proper functioning of the lab operation.
Monitor the testing techniques and accuracy of all records and documentation that is done in the lab.
Implement new testing standards and policies as needed.
Ensure completion of all testing, including special project/protocol testing in a timely and appropriate manner.
Identify potential risks associated with laboratory operations and lead teams to resolve lab issues.
Assist in implementing quality and regulatory requirements (e.g., FDA, GLP, QSR, cGMP, USP, and CDR rules, and guidelines), and ensure compliance with testing SOPs and specifications.
Participate in continuous improvement initiatives that impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.
Collect and present appropriate laboratory testing metrics.
Maintain expenses at or below budget for the lab.
Ensure department readiness for audits by both internal and external authorities. Represent Quality Management for microbiology and interface with investigators during these inspections.
Ensure equipment maintenance, calibration, and internal audits performed.
Maintain Safety requirements of lab and lab personnel.
Education and Experience Requirements:
BS in Microbiology, or biological science
8+ years of relevant Quality experience, including previous supervisory/management level experience, in a CGMP biologics manufacturing facility, preferably with experience supporting a commercial product.
Hands on skills and knowledge of Quality lab operations including the operation and troubleshooting of lab equipment.
Demonstrated experience managing projects and/or participating in project teams, including teams across multiple geographies.
Strong interpersonal skills including the ability to present to personnel at all levels and with varying levels of technical expertise
Strong understanding of the regulatory requirements of the biopharmaceutical industry.
Proficient in Microsoft Office – Outlook, Word, Excel, Powerpoint Working Conditions
Normal office working conditions: computer, phone, files, fax, copier.
Personal Protective Equipment must be worn as required
Quality Control Analyst III
Quality Control Analyst II (2)
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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.