Shire QA Disposition Lead US External Biologics (Associate Director) in Lexington, Massachusetts

Primary Role

Works in the External Biological QA team of Shire United States (US) Quality Assurance. This unit includes oversight of external drug product manufacturing at contract manufacturers and batch release.

This individual will support all disposition activities related to external commercially manufactured medical device, drug substance, drug product and finished drug product. The AD is accountable for defining and achieving the functional area goals and objectives as they relate to departmental and Shire goals. Responsible for adhering to domestic and international GMP regulations, cGMP’s, company policies, performance management and department budget.

The position may require approximately up to 10% travel.

Responsibilities

This position is responsible for review and release of all records associated with external manufacturing including drug substance, fill/finish bulk product and finished drug product. Supports cold chain and evaluation of cold chain as related to movement of drug substance, drug product, and finished drug product to the end user. The individual may be responsible for, but is not limited to:

  • Meeting functional area goals and objectives as they relate to departmental, external operations team, and Shire goals

  • Leading and executing biologic drug product and finished drug product batch disposition in accordance with priorities and regulatory commitments to meet the quality objectives and inventory demands.

  • Coordinating, scheduling, prioritizing and follow up with regulatory filing updates and associated change controls.

  • Serving as the QA liaison between internal QA, QC and Internal QA as related to relevant quality investigations and ensuring GMP compliance for batch disposition.

  • Escalating quality events as per company’s procedures.

  • Overseeing all quality systems: SOPs, specifications, executed batch records, deviations, CAPAs and change controls as related to disposition.

  • Convening Material Review Board (MRB) in line with company procedures related to complex investigations impacting product disposition

  • Overseeing product specification development and Certificate of Analysis approvals.

  • Overseeing of quality systems and metric development and reviews for routine monitoring and continuous improvement.

  • Contributing to product complaint investigations for US and any US supplied product to International regions.

  • Hiring, training and developing qualified staff to ensure effective execution of roles and responsibilities, GMP compliance, and attainment of operational and development goals.

  • Maintaining daily staffing requirements to meet business needs.

  • Ensuring incorporation of continuous improvement initiatives to proactively mitigate current and future risks to maintain an effective operation to support business needs along with active participation in Leading for Daily Improvement (LDI) initiatives.

  • Efficient and timely reporting of key performance indices (KPI) related to batch disposition activities

  • Collaborating with counterpart in EU to ensure dispositions teams are aligned with harmonized processes.

Education & Experience Requirements

Minimum requirements include a Bachelor’s degree in a technical, preferably with a biological science discipline and 8+ years pharmaceutical and/or biopharmaceutical industry experience. An advanced degree or other industrial certification is a plus.

Detailed knowledge of Title 21, CFR Parts 210, 211, 600 is essential. Knowledge of EU GMPs is a plus.

Industry experience (Quality or Manufacturing) working with biological drug substance manufacturing processes, sterile fill/finish operation is essential. Experience of working with contract manufacturing organizations is desirable.

Experience in dealing with regulatory bodies (e.g. FDA, ANVISA, EMA, Health Canada).

Proven people manager and leader capable of developing people and teams is preferred with at least 5 years of Quality Assurance / Quality Control management experience.

Other Job Requirements

Periodic domestic travel is required for business meetings with regional Quality team, corporate peers/collaborators, vendors/contractors, and to stay current with professional development opportunities

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.