Shire QA Supervisor- Packaging 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.

Incumbent will be the QA Lead for packaging operations, sterile injectable filled vial inspections and AQL inspections. This position will be required to partner with multiple manufacturing managers for rapid problem solving and influence decisions.

Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements and apply knowledge for daily decisions and packaging operations design approvals.

Strong interpersonal skills and great attention to detail are necessary. Must be able to influence decisions based on regulatory knowledge, and must have excellent problem solving, and verbal and written communication skills.

Must be a strategic thinker and be able to develop strategic objectives.

Must have the ability to manage people, encourage teamwork and drive actions based on strategy. The position will include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner, evaluate, train and develop direct reports.

Must be a self starter who need minimal oversight and can identify gaps and develop required work flows to lead teams and achieve project and strategic objectives

Direct performance of in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.

Develop plans to correct identified risks including areas of non-conformance and approve and device strategy to implement effective Corrective action plans.

Write, review, analyze and revise written Standard Operating Procedures (SOPs) and support development and review of Protocols, Qualifications, Regulatory Submissions, etc.

Review of Deviation investigation and change control records.

Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills.

Must have experience in visual inspection, preferably of large volume filled glass solutions, and packaging operations.

Education: Bachelor's degree in science or engineering. Minimum of 5-8 years of related experience in pharmaceutical, biotechnology or related industry making Quality decision based on regulation requirements.

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.