Shire Director, Quality Labs in Los Angeles, California
Directs the Quality Control Laboratories (Microbiology, Biochemistry, Lab Operation Support, QC Compliance) and Quality Receiving and Inspection in a large size department to support Facility and Corporate wide initiatives at the Los Angeles and Van Nuys Facilities. Responsible for results in terms of product Quality and Conformance to Regulations and Shire policies. May act as Quality Management Representative for the Facility in the absence of the QMR.
Essential Duties and Responsibilities
Develops and deploys the Quality Systems (e.g. laboratory investigation, out of specification investigations, LIMS, assay validation, management review, CAPA, and process control) that ensure products conform to defined requirements.
Understands and deploys processes to assure conformance to regulations. Actively leads or presents in regulatory inspections.
Periodically reviews the suitability and effectiveness of the Quality System with Executive Management.
Interacts frequently with all levels of internal management as well as across functional and business units.
Manages interactions with customers and regulators concerning the Quality of products, systems, and processes.
Identifies and manages continuous improvement projects that may span multiple sections or departments with objective of achieving Quality, reliability and cost improvements. Actively supports/directs strategies to continuously improve laboratory appearance, laboratory processes and results.
Responsible for adherence to specification and procedures that have been established to ensure product Quality in area of responsibility.
Oversees the development and implementation of standards, methods, procedures and sampling for inspection testing and evaluating the precision, accuracy and reliability of the product.
Develops 3 to 5 year strategy for the organization.
Develops operational budget and capital budget for Quality Control organization. Completes budget and adheres to budget/forecast. Continues to determine Value Improvement Projects (VIP) to lower operational costs and improve lab efficiency.
Directs organization of 4-5 direct reports (Managers) and approximately 150 indirect headcount. Manages overall coaching, training, development and succession plans for the team.
Member of the Facility Senior Leadership Team (SLT) and Quality Leadership Team (QLT).
In depth knowledge of the regulatory environment for manufacture of biological products. Includes strong knowledge of FDA, EMA, and ICH regulations and UISP, EP, and JP requirements.
Strong drive for continuous improvement activities within the lab.
Strong leadership skills and demonstrated success in managing a large team. Ability to build layers of succession within the organization and talent pipeline.
Strong analytical problem solving skills.
Excellent verbal and written communication skills.
Success working with multifunctional cross facility global teams.
Excellent interpersonal/communication/influencing/negotiation skills required.
Demonstrated problem solving skills.
Education and/or experience
- Typically requires bachelors' degree, preferably in science, engineering or other related technical field. 10+ years of related experience with 7+ in a management role
Must be able to lift, push, pull and carry up to 10 lbs.
In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
Must be able to work in controlled environments requiring special gowning.
Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn.in the manufacturing environment
Will work in a cold, wet environment
Must be able to work multiple shifts, including weekends.
Must be able to work overtime as required. (only for non-exempt positions)
May be required to work in a confined area.
Some Clean Room and cool/hot storage conditions.
Notice to Employment / Recruitment Agents:
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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.
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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.