Quality Management Rep

Job Description

Bio Life Plasma Services, a subsidiary of Takeda Pharmaceutical Company Ltd., seeks an experienced quality professional to monitor all systems and activities ensuring source plasma manufacturing is performed consistently according to cGMP, the Shire Quality System, and applicable regulations.

The incumbent monitors compliance, ceases operations or shipments if donor or product safety is compromised, and maintains complete accurate records in accordance with cGMP.

• Regulatory Compliance (15%) – Stay current with federal, state, local and company-specific rules, ensure center compliance, keep SOPs current, and observe staff following SOP.
• Plasma Collection Center Quality Assurance Oversight (80%) – Review operational records, track deviations, report errors to management, stop operations when needed, identify SOP revisions, collaborate with managers for audits, evaluate corrective actions, conduct monthly QA audits for critical control points, coordinate review meetings, and participate in staff meetings.
• Employee Recruitment and Retention (5%) – Provide feedback on quality staff, participate in performance evaluations, foster teamwork, resolve conflicts, support staff evaluations, and ensure customer service satisfaction.

• Technical/Functional – Minimum one-year relevant experience or equivalent education/experience; medical or regulated field experience desirable; plasma collection industry experience preferred; strong computer skills; awareness of QA in FDA-regulated environment.
• Leadership – Integrity, fairness, honesty, perseverance; customer focus; decision‑making and autonomy; communication; coaching; innovation; improvement initiatives.

• Essential – High School Diploma or equivalent.
• Desired – Associate’s or Bachelor’s degree.
• Skills – Organizational, technical, problem‑solving, leadership, communication, coaching, initiative, and continuous improvement.

• FLSA Classification:
  Exempt.
• Other duties as assigned.

• Base salary range: $63,080.00 – $86,735.00 (location: Indianapolis, IN).
• Benefits: medical, dental, vision, 401(k) with company match, short‑term and long‑term disability, life insurance, tuition reimbursement, paid volunteer time, company holidays, well‑being benefits, sick time, paid vacation.

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, sexual expression, age, disability, citizenship status, or any other characteristic protected by law.