Shire Mnf. Systems Compliance Lead in Social Circle, Georgia

Description:

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmic.

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.

Manage through subordinates the coordination of all investigation activities of a section or department in the Manufacturing organization. Responsible for meeting budget, quality, and production goals, setting standards, and making employment and staffing decisions. Interprets manufacturing policies, procedures, and programs.

Managing timely lot release Responsible for meeting production requirements, delivering quality products to customers in a timely fashion and cost-efficient manner. Identify/prioritize/provide resources to assist the department manager to meet department goals. Supervise and coordinate complex investigations and root cause analyses. Implement sustainable control systems on the shift or multiple shifts to eliminate product discrepancies and minimize CAPA events. Commit to employee feedback and developmental processes. Provide a positive and equitable working environment emphasizing the Shire values. Support and emphasize the Safety and Quality commitments of the department. Make staffing decisions. Investigate and resolve disciplinary issues up to and including suspensions and terminations.

Will be responsible for driving operational excellence and flawless execution in the areas of cost reduction, discard reduction, regulatory excellence including exception reduction and internal/external regulatory commitment management, on time delivery and lead time reduction, improving the overall safety of the work environment, leadership development and the ability to create a vibrant continuous improvement culture based on the principles of QLP, Lean Manufacturing, total employee involvement and DMAIC problem solving.

Requirements:

Education and/or Experience :

Ability to manage activities of departments through subordinates who exercise full supervision in terms of cost, methods, and employees. Ability to interpret and analyze statistical data and information and financial reports, understand and resolve technical difficulties, interface with internal engineering/technical experts and external technical representatives, manage multiple priorities in a manufacturing plant setting, be resourceful to a large manufacturing department. Knowledge of World Class manufacturing methods (QLP, Lean, Six Sigma), Good Manufacturing Practices, Food Drug and Administration guidelines and process validation.

Requires a B.S. or equivalent, preferably in a technical discipline. 5-7 years experience in all aspects of the manufacturing process.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

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.

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.