The Senior Manager Packaging Quality Assurance (QA) is responsible for creating and implementing strategies for the critical functions of Packaging and Analytical Chemistry support within Manufacturing QA to ensure the quality and compliance of TPUSA commercial products. This position interacts with US and international vendors for product manufacturing, packaging and analytical operations, as well as Takeda’s Global Development and Manufacturing sites.
Qualifications EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Design and lead strategic compliance project efforts related to product packaging and stability/analytical testing for TPUSA QA.
- Define and implement compliance strategies, quality plans and Commercial Quality Assurance programs for the management of Takeda outsourced packaging and stability/analytical operations to assure the quality and compliance of TPUSA and CCO commercial products.
- Independently and directly represent Takeda to make decisions on acceptability of Third Party Packagers’ and Analytical Testing Laboratories’ quality programs and daily activities.
- Establish TPUSA QA expectations for third party vendors, perform strategic systems reviews and risk/benefit analyses of supplier processes and systems to assure compliance with cGMPs and Takeda Quality System expectations.
- Advise project teams on testing strategies for new or existing TPUSA or affiliate products to ensure cGMP and Takeda expectations are met. Ensure the establishment of remediation plans if needed to improve analytical testing strategies.
- Manage staff responsible for the day to day quality operations and interactions with vendors, to assure timely disposition of Takeda product while ensuring compliant operations. Makes recommendations regarding long-range resource planning, budgeting and restructuring to meet Takeda and project needs.
- Provide leadership in the assessment of critical changes or deviations within our supply chain, to assure compliance to regulatory commitments, assessment and evaluation of risks, appropriate disposition of product and system correction or improvement of operations to minimize future risks.
- Maintains awareness of relevant legislation and regulatory guidelines and provides interpretation of regs, and assures that QA vendor management programs, systems and controls are reviewed and updated as needed to assure compliance. Monitors business environment at supply chain partners to ensure compliance objectives are met.
- Ensure successful and timely completion of all product submissions, product launches and new Supply Chain initiatives within Takeda, as well as at our packaging, warehousing and stability/analytical operations.
- Assist with FDA inspections of TPUSA, TDC or third party vendors associated with the commercial product supply chain. May represent Takeda during regulatory inspections, as needed.
- Develop audit expectations for third party manufacturing operations per TPUSA audit program, compliance needs and business needs and ensure completion of audits. Lead audits of existing or new Takeda contractors or suppliers for due diligence activities, PAI or Takeda Audit Program to ensure compliance with Takeda Quality expectations. Review performance of qualified and new auditors on staff.
- Identifies trends and emerging issues at vendors and implements corrective actions as needed.
- Additional duties as assigned.
- Bachelor’s Degree in Chemistry or related discipline and 12 years of QA/QC experience in the pharmaceutical industry and QA/QC laboratory environment.
- MS in Chemistry or related discipline desired
- 10 years experience in pharmaceutical manufacturing, packaging or laboratory environment
- 4 years of people management experience desired
- Expertise in cGMPs and other pertinent regulations
- Project Management expertise desired
- Skills required:
- Communication – ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner.
- Analytical Skills – ability to analyze a wide variety of information and data to make management decisions regarding potential risks associated with product quality or regulatory violations.
- Leadership – ability to effectively lead and motivate a team of direct reports, build on strengths, and address areas for improvement.
- Teamwork – ability to establish professional relationships and rapport with internal and external peers and higher-level management
- Proactiveness – ability to anticipate potential problems and risks related to commercial product operations, investigate solutions, and implement preventive actions.
- ASQ or other Quality related certifications preferred
- Being seated at desk using manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Due to the requirements of supporting pharmaceutical production operations and conducting audits of third-party vendors, the work environment includes exposure to production and processing facilities such as:
- Pharmaceutical manufacturing and packaging
- Active pharmaceutical ingredient manufacturing
- Packaging materials
- Printed commodities
- Analytical laboratories
- Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 25% travel.
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