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.
This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.
- Responsible for quality operations for purification, aseptic filling,and final packaging and ensures products conform to defined requirements.
- Responsible for final product release and intermediate continued processing. Manages associated metrics.
- Understands and deploys processes to assure conformance to regulations. Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility.
- Acts as advisor to subordinates to meet schedules and/or resolve technical problems. Manage, identify, hire and develop and recognize technical staff.
- Utilizes solid understanding of theories and practices of a variety of disciplines to manage complex projects or programs within boundaries of quality, time, budget and regulatory requirements.
- Subject matter expert during regulatory inspections internal audits.
- Identifies and manages continuous improvement projects that may span multiple sections or departments with the objective of achieving quality, reliability and cost improvements.
- Develops budget for their cost center(s) and ensures adherence to the budget.
- Manages overall coaching, training, development and succession plans for the team.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- In depth knowledge of the regulatory environment for manufacture of medical products.
- Strong analytical and problem solving skills. Must be able to break down complex problems and tasks into activities capable of being performed by personnel
- Candidate must excel at working within a dynamic, hands-on, team based environment with limited supervision.
- Excellent interpersonal/communication/influencing/negotiation skills required
- Strong leadership skills and demonstrated success in managing a large team.
- Success working with multifunctional, global teams.
- Excellent verbal and written communication skills.
- May be considered a Subject Matter Expert (SME) in various disciplines – particularly in the areas of purification of plasma based products (or other biopharmaceutical manufacturing), aseptic filling (isolator experience is preferred), inspection and labeling/packaging.
BS in science or engineering; advanced degree helpful.
Minimum of 10 year’s experience in Quality, Manufacturing or related field in the medical products industry.
7 years management experience.
Location/Region: Social Circle, GA