Shire Compliance Investigator III - Lead in Los Angeles, California

This position oversees and coordinates the operational aspects of ongoing compliance projects and serves as a liaison between project management and planning, project-team and line management. This position will also manage projects of small to large size scope, in a timely and cost-effective manner. This position is responsible for developing resolutions to meet timelines, goals, and objectives in alignment with the overall department strategy. This position will initiate events as needed, conduct root cause investigations, and close events for Manufacturing under the direction from Compliance Management. Support in assigning proper corrective actions and facilitate implementation.

Essential Duties and Responsibilities

  • Work with a cross functional teams to ensure that compliance gaps are appropriately addressed.

  • Write and manage events

  • Lead Kaizens and problem solving sessions for high level and complex events, including contamination.

  • Represent events and investigations during audits.

  • Using investigation/lean tools develops robust root cause analysis and drives robust actions to ensure elimination of root cause.

  • Responsible for driving closure of investigations and events to support lot disposition.

  • Develop strategies and drive right first time (RFT) and event reduction goals.

  • Ensure projects and improvements implemented per established timelines.

  • Teach and coach less experienced investigators.

  • Expert with selecting and executing troubleshooting/investigation tools.

  • Quality system and manufacturing SME.

  • Utilize engineering tools to solve problems (e.g., FMEA, Finite Element Analysis, Process Modeling, Design of Experiments, Mold Flow, SPC, software development).

  • Interacts through program updates and reviews with all levels of management.

  • Write and manage events (CAPA investigations, UIs, ICARs, OOXs, containment and/or corrective actions) under the direction of Compliance Management.

  • Other duties as assigned..

Qualifications

  • Ability to drive change and motivate others toward a common vision.

  • Ability to lead teams that are not direct reports.

  • Effectively compile and interpret data.

  • Demonstrated facilitation, problem solving, and analytical skills

  • Demonstrated sound judgment. Must be confident, resourceful, self-reliant and self-motivated.

  • Knowledge of manufacturing process and equipment

  • Strong knowledge of Quality Systems.

  • Strong interpersonal/influencing/negotiating skills.

  • Strong communication and presentation skills, both oral and written with a demonstrated ability to present key quality/department/business indicators to senior management.

  • Strong project management, organizational, planning and analytical skills.

  • Must have a working knowledge of project management and investigation/lean tools and possess knowledge of related disciplines.

  • Excellent Microsoft Office Suite knowledge (e.g., Excel, PowerPoint, Project, etc.).

Education and/or experience

High School Diploma or GED plus 5+ years of related experience OR Bachelors' degree in science, engineering or other related technical field and 2+ years of related experience. Some leadership experience preferred.

PMP (Project Management Professional), Lean/Six Sigma, and/or Lead Investigator Training Certification is preferred. Prefer experience with TQM methods.

Physical Demands

  • Must be able to lift, push, pull and carry up to 25 lbs.

  • In general, the position requires a combination of sedentary work and walking around observing conditions in the facility

Working Environment

  • 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.

  • 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.

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.