Newly combined with Baxalta, Shire is now the leading global biotechnology company focused on serving people affected by rare diseases and highly specialized conditions. These diseases are often misunderstood, undiagnosed and life-threatening. Our 22,000 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.
At Shire, we are dedicated to expanding, building and sustaining leadership across our key therapeutic areas through our extensive portfolio of products, innovative pipeline and collaborative approach to working with diverse partners around the globe. We strive to earn and keep the trust of our patients, their families and physicians, and all others who support and advance their care. Working together, the possibilities for our patients, healthcare partners and employees are unprecedented, with significant growth potential for our shareholders.
Responsible for providing overall plant Quality support and training. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules, guidelines, and Shire quality practices. Responsible for the development, implementation, coordination, and evaluation of learning and development (L&D) initiatives. Acts as local Database System Administrator and subject matter expert for the Learning Management System (LMS).
Essential Duties & Responsibilities:
Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques.
Determine the logic, adequacy and effectiveness of processes, systems and related requirements.
Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans.
Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
Serve as Subject matter Expert (SME) and provide training to local employees as needed on relevant area(s).
Serve as a back-up for functions within quality such as batch review or batch release.
Maintains complete and accurate records to ensure that all personnel are competent to perform their assigned duties.
Assists with identifying operational opportunities for continuous improvement and initiating changes to processes as needed.
Provides support to the Senior Leadership Team (SLT) and facility Quality Management Representative (QMR) to manage internal and external audits, including audit preparation, control room facilitation, generation of training compliance reports, and audit interface as Subject Matter Expert.
Works closely with the SLT and QMR to communicate employee needs as they relate to training.
Conducts stand-up, instructor led classroom training.
Ensures timely completion of cross-training and annual re-certification training.
Manages and coordinates the periodic review of training materials, modules and curriculums.
Monitors facility training needs and performs additional training activities as needed.
Provides regular communication to supervisors regarding training to ensure compliance with training requirements and that adequate support is provided to employees in the work area.
Compiles, analyzes, and presents training metrics to the SLT at monthly Quality Data Review and quarterly Management Review.
Strong interpersonal skills and great attention to detail are necessary. Must be a strong team player with good problem solving, and good verbal and written communication skills. Must have the ability to manage people, encourage teamwork and drive decisions.
Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices as appropriate.
Familiarity with federal and local requirements regarding the training of personnel and related record keeping.
Demonstrated ability to convey technical information to others.
Effective coaching, counseling, and communication skills are essential.
Demonstrated ability to multi-task and prioritize while providing excellent customer service.
Must be detail oriented, have the ability to meet deadlines, and handle sensitive, confidential information on a regular basis.
PC skills including IsoTrain and a solid working knowledge of Microsoft Office software (Excel, Word & PowerPoint) are required.
Ability to work in a highly matrixed environment.
Exceptional facilitation / presentation skills.
Bachelor's degree (Business, HR, psychology, or education preferred) and a minimum of 2 years of relevant work experience within the most recent 5 years, preferably in a regulated industry or an equivalent combination of education and experience.
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.