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Supplier Quality Specialist

5 months ago

Philadelphia, United States WAPT Full time

Overview:

WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.

Working at WuXi Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning.

Our benefits include:

  • 401K matching
  • PTO
  • Employee discount programs
  • Medical, dental and vision insurance
  • and much more

The Supplier Quality Specialist executes qualification, maintenance, and monitoring for WuXi suppliers with an emphasis on continuous improvement, global alignment, risk management, and supply chain reliability. This role will be responsible for the ongoing maintenance and execution of the Supplier Management Program and day to day vendor management.

Responsibilities:
  • Supplier Management/Qualification process owner: conducts onsite/paper audits of suppliers and ensures adherence to the Supplier Qualification Program.
  • Leads the scheduling of Supplier audit schedule, and preparation; including identifying SMEs and audit team members.
  • Leads supplier CAPA plan approvals with team, for timely closure of audits.
  • Manages supplier complaints and non-conformances (SCARs) to ensure root cause is addressed with timely and effective corrective and preventative actions employing proper root cause analysis methods.
  • Supports local and global cross-functional stakeholders on matters pertaining to supplier controls, significant concerns related to Quality System performance, issue escalation, procurement strategy, and regulatory compliance.
  • Participates in regulatory, client and internal audits for all supplier management inquiries.
  • Supports the investigation and resolution of deficiencies related to Supplier Quality.
  • Maintains Approved Supplier List and manages supplier folders/ Vendor Cards/ profiles; centralizing and organizing all Supplier Quality Program records. (Supplier Change Notifications, Change Controls related to Suppliers, Quality Agreements).
  • Implements supplier change management process including change notification, dissemination of information, impact assessment, approval of changes, and support material/supplier qualification; escalate and manage appropriately to meet company requirements.
  • Creates and maintains standardized metrics that guide actions and promote continuous improvement (e.g. supplier performance, SCAR responsiveness, etc).
  • Actively participates in continuous improvement initiatives.
  • Develops and implements procedures for compliant and effective Supplier Quality Systems.
  • Effectively utilizes tools and resources to improve program compliance.
  • Works with Procurement and internal stakeholders in resolving supplier performance issues
  • Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards.
  • Ability to work in a team environment and independently as required
  • Contributes to the overall operations and to the achievement of departmental goals.
  • Performs job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
  • Ability to accomplish the described duties through the use of appropriate computer equipment and software (Microsoft Word, Excel, Outlook, and Access).
  • May be required to work Holidays and weekends.
  • May be required to perform supplier audits.
  • Performs other duties as assigned.


Qualifications:

Experience/Education:

  • Bachelors degree required
  • 5 years working experience in a Biotech/Pharmaceutical environment is required; preferably, with at least 1 year focus on supplier quality.
  • Experience working in a GMP environment and in a Pharmaceutical or Medical Device industry
  • Quality auditing certification, preferred

Knowledge/Skills/Abilities:

  • Thorough working knowledge of Regulatory Compliance, Quality System Management and Quality Assurance principles and practices. Strong knowledge of 21 CFR 210 and 211.
  • Experience in 21 CFR 58, PTC guidelines and ISO 17205 requirements, preferred
  • Experience in the development and improvement of Quality Systems
  • Ability to use judgment, clear problem-solving and decision-making skills.
  • Ability to work under limited supervision and to handle complex problems.
  • Excellent organizational and interpersonal skills. Ability to communicate effectively with all levels of the organization.
  • Ability to build and maintain relationships with internal and external customers
  • Highly functioning team contributor in a multi-skilled, dynamic business environment
  • Proficient in Oral & Written communication skills
  • Need to be able to read, write and understand English
  • Proficient in Microsoft (Excel, Word, Outlook)
  • Travel is required 15-20% , Domestic/International, Daily/Overnight

Physical Requirements:

  • Must be able to work in an office environment with minimal noise conditions.
  • Must be able to work in Lab setting with exposure to biohazards / Chemicals
  • Must be able to wear appropriate PPE
  • Ability to stand /Sit/walk for long periods of time
  • Must be able to perform activities with repetitive motions

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

Our Values:

Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.

Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.

WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.