Shire Sr. Quality Associate in Social Circle, Georgia

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 Ophthalmics.

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.

  • Execution Lead for the Quality System element(s) assigned:

  • Ensures that the Quality System elements assigned comply with the global process and regulations.

  • Collaborate and communicate with global function and sister sites to align on goals and best practices.

  • Ensures that quality system metrics / trends are reported as established by the site and/or internal Quality System metrics.

  • Leads ongoing daily departmental activities, oversees actions of self and direct reports

  • Provide training, guidance, and coaching for the direct reports.

  • Manages hiring and training of new team members

  • Annual goal setting for self and team

  • Performance evaluations for direct reports

  • Ensures developmental planning for self and team members

  • Conducts 1:1 with team members.

  • Plans and schedules the work of direct reports.

  • Assists other departments in understanding the achievement of quality goals in an efficient, accurate, compliant and timely manner.

  • Participate in DMAIC projects in the role of contributor, coordinator or leader.

  • Support internal and external audits as necessary

Requirements

  • Understand and able to perform all the primary activities as defined in QAI and QAII jobs

  • Strong technical writing skills

  • Sound decision making and problem solving skills

  • Understanding of manufacturing processes

  • Understanding of quality systems element

  • Proficient in utilization of Quality Systems such as TrackWise, VEEVA

  • Demonstrates solid communication skills (verbal and written) with management and peers and be able to work cross-functionally with other groups.

  • Must demonstrate effectiveness in supporting continuous improvement and promoting the control and prevention of potential issues

  • Solid presentation skills are required.

  • Data analysis skills are required

  • Previous supervisory experience.

Qualifications:

  • Bachelor degree in science, engineering or other technical field.

  • Five (5) + years related experience

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

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.