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Quality Compliance Specialist II

Job ID 1603092 Date posted02/15/2017 LocationCambridge, Massachusetts, United States;
More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

OBJECTIVES:

Assists in coordination of activities to investigate and close product complaints for marketed products and other  products as assigned. Works cross-functionally with other departments, Takeda Alliance Partners and Takeda Affiliates to ensure thorough investigation plans are developed and executed for timely and compliant closure of product complaints.

ACCOUNTABILITIES:

Primary:


Product Complaint System Oversight:

Performs and/or coordinates the receipt, processing, monitoring and reporting of product complaints.  Addresses and expedites product complaints under the company’s product complaint policy and procedures, and ensures compliance with federal regulations.

  • Logs and maintains currency of product complaint documentation utilizing the product complaint tracking database.
  • Coordinates the activities required to investigate and close Commercial product complaints, which includes following-up with Takeda’s contract call center and/or complainants, and facilitating cross functional product complaint sample inspections and analyses by applicable Takeda departments and Alliance Partners.
  • Authors and sends Commercial complainant responses per established procedures and timelines.
  • Monitors and analyzes product complaint data for trends, ensuring that appropriate corrective action plans are developed and routine status and trending reports are distributed to management.
  • Escalates to management (as applicable), any identified risks, improvement opportunities and/or compliance concerns associated with the product complaint system. Provides suggestions to appropriate company authorities to modify existing manufacturing or packaging processes based upon pattern and related analyses.
  • Co-facilitates periodic review meetings between Pharmacovigilance, Medical Affairs, Commercial Operations and Quality per Takeda procedures to ensure consistency of processing and reconciliation of product complaints and adverse events.
  • May attend weekly Case Review Meetings (routinely) and Signaling Meetings (when applicable as backup), providing input on behalf of Commercial Quality Operations
Secondary:

Commercial Quality Operations:

Provides support for other Commercial quality operations as assigned.
  • Interacts directly with internal customers at a peer level and with support personnel at suppliers.
  • May provide training, as assigned, on department-specific procedures and systems.
  • May provide subject matter expertise for the Quality Assurance group during internal, vendor and Alliance/Corporate Partner compliance or regulatory audits, when appropriate.
  • May write, review, and some approvals of controlled documents.
  • Collects data, calculates, & reports on performance metrics.
  • Identifies and proposes process and system improvements.

Special Projects:

  • Supports Oncology and Biologics Quality in the timely implementation, assessment and closure of Commercial related projects and operations, as  assigned.
  • Assists to compile Annual Product Reviews for Takeda Commercial products.

Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelor degree, 4+ years of biopharmaceutical experience
  • Knowledge of cGMP regulations for US, EU and other markets
  • Effective time management skills, detail oriented, organizational skills, teamwork and collaboration
  • Strong computer, verbal and written communication skills
  • Prior experience handling of commercial product complaint report investigations

PHYSICAL DEMANDS:

  • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
TRAVEL REQUIREMENTS:
  • ≤10% potential domestic or international travel



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