Shire Head of Quality Assurance, Los Angeles Site (Director) in Los Angeles, California
This position is responsible for determining the strategy and directing the activities of Quality Assurance and product release for both Fractionation and Pharma departments in the Los Angeles Facility. Processes include teardown, fractionation, bulk purification and final formulation. Additionally, this leader has the ultimate responsibility to ensure the implementation and on-going maintenance of prevention-based quality system including exceptions management, CAPA, etc. The incumbent will be a member of the Senior Leadership team at the site and develop mid- and long term strategy. Additionally, will partner up with the manufacturing Business Leaders to drive improvements in safety, quality, compliance, financial performance, employee development, customer satisfaction, and continuous improvement initiatives consistent with the Plant Strategic plan and our company supply value proposition.
Essential Duties and Responsibilities
Manages the Quality organization in a large size plant specific to the areas of fractionation and bulk purification and product release.
Assumes final accountability for all product quality release decisions.
Ensure compliance to all applicable state, federal, and international regulations.
Manage interactions with internal external customers concerning the quality of products, systems, and processes.
Develops and deploys mid and long term strategy and operational excellence, training/education, talent review and personnel development.
Serves as the primary interface for all inspections and audits of in-process quality management, exception management and CAPA.
Direct the ongoing continuous improvement initiatives.
Staff the department appropriately to ensure compliance to all process quality requirements in accordance with the quality plan.
Manages overall coaching, training, development and succession plans for the team.
Develops and ensures adherence to the department budget.
Thorough knowledge of the manufacturing operations, applicable procedures, specifications, regulations, and standards.
Strong analytical and problem solving skills.
Good verbal and written communication skills
Ability working with multifunctional, global teams.
Good interpersonal/communication/influencing/negotiation skills required.
Ability to manage/supervise a team of employees.
Demonstrated problem solving skills.
Prior experience in interfacing and leading regulatory audits.
Ability to manage department budgets and staffing.
Living our ethical principles and leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following: Leadership Behaviors
Be Results Oriented
Be An Excellent Manager of Self and Others
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, which in some areas is cold and wet, and require personal protective equipment (PPE).
Must be able to work multiple shifts, including weekends.
May be required to work in a confined area.
Some Clean Room and cool/hot storage conditions.
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.
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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.