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.
QMS Lead Quality Transformation
This quality leadership position is responsible for full deployment of a transformed Quality Management System for the US sites. The individual will be a core team member for the Transformation Team, providing the change management plan and support needed to be successful. The individual and team will frequently visit the manufacturing sites to understand and mitigate any deployment challenges, and to coach the sites on the new Mindset behind the transformed system: being more flexible, nimble, and innovative. Also responsible assuring solid training in GMPs for operations.
QMS Deployment Support (80%)
Training, Quality Comprehension (20%)
• Manage a team of change agents in support of continued improvement in nimble and flexible quality systems. Also manage the Compliance training support team.
• Ensure full and sustained deployment of newly integrated, transformed Quality Management System Elements ensuring compliance to regulatory requirements; and driving consistency with corporate standards.
• Develop and deploy strategies to assure understanding (Mindsets) of the behaviors and tactic in executing against thee quality systems.
• Partner with key stakeholders, e.g. manufacturing, engineering, vigilance, regulatory, PSTO, etc. to assure the deployment of an overall effective quality system.
• Communicate significant quality systems issues to senior management
• Attend weekly Global PMO meetings
• "Walk the halls" at each site/entity within a region; actively look for opportunities to engage employees in their decision-making and reinforce the quality principles
• Attend on-site "decision review meetings" led by local managers and supervisors to course-correct behavior
• Work with Core Team to develop action plans for sites that are off-track in adopting the change
• Continually assess and analyze all elements of the quality systems and recommend actions to improve them.
Key Skills and Competencies:
• Experience with managing global Quality Systems an FDA regulated manufacturing setting
• Thorough knowledge of applicable procedures, specifications, regulations and standards, including ISO 9001, ISO 13485, FDA 21 CFR Parts 210, 211, 600, 820 and International GXPs.
• Strong analytical and problem solving skills.
• Ability to lead change across multiple facilities
• Strong communication and leadership skills.
• Strong interpersonal, communication, influencing, and negotiation skills
• Strong computer skills, excellent writing, organization, and presentation skills.
Must be able to travel (25-50%%)
• Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:
• Be Positive
• Be Accountable
• Be Results Oriented
• Be An Excellent Manager of Self and Others
• Design and deployment of the Quality System Elements
• Variance allowed for certain local sites, if any
• Cultural alignment approaches, including Mindset Training
• Present in Lexington, MA sufficient to cover responsibilities above (~week/Quarter)
• Travel in support of sites use and defense of the Quality System (25%)
Education & Experience Requirements
• Bachelors degree in a science related field
• 5-10 years quality leadership experience in an FDA regulated industry
• Master Degree in science or Quality Assurance
• ASQ Certified Quality Manager
• Experience with Medical Devices, Biologics, Blood Products, and small molecules
• Experienced in a role responsible for developing and deploying GMP training
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.
EEO is the Law
EEO is the law - Supplement
Pay Transparency Policy
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.