Senior Specialist, External Quality

Job Description

Position Overview

Individual contributor role responsible for ensuring that all products managed by External Quality Assurance (EQA) are manufactured packaged analyzed released stored and distributed in conformance with all applicable regulatory requirements regulatory filings and company policies.

Role has primary batch release responsibility and ensures that effective and robust Quality systems are in place to comply with required regulations policies and guidelines governing the External Party manufacture and release of API intermediates API non-sterile pharmaceuticals sterile pharmaceuticals.

Essential Functions and Responsibilities (Includes but are not limited to)

The Sr Specialist External Quality is responsible for:

Primary functions and responsibilities of the role:

• Act as Qualified Person (QP) where applicable to certify the batches of Finished Good products to be released in the EU Market under requirements of European Laws & applicable regulations

• Support New Product Introduction and other process transfer/validation activities at partner sites where required

• Act as delegate for EQA Associate Director roles when required

• Evaluate and/or release products with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations

• Manage/coordinate internal and external partner deviations and complaints as required assist in the coordination of significant investigations including Fact Findings and RCA risk assessment support on critical issues to prevent disruption to supply

• Review and approve changes to master batch records

• Act as owner for change controls and change tasks as required

• Support collection and compilation of documentation needed for regulatory filings/submissions when required

• Operate in a safe and efficient manner and in compliance with the Safety and Health Policy

The Sr. Specialist External Quality is also responsible for:

• Initiate & lead quality improvement projects new Quality Systems introduction and other assignments as per business needs

• Provide training and coaching as required

• Collaborating with internal and external stakeholders EQA Compliance Team and other ExN Platforms as part of cross-organizational engagement approach

• Participating in external partner site visits and GEMBA as required as part of ongoing EQA oversight activities

• Serves as Quality SME for EQA; Maintains and provides expertise on EQA quality and/or business systems tools data and processes on an ongoing basis

• Amount of Travel Required: <10% travel

Qualification and and Skills Requirements (Includes but are not limited to)

Education and experience required for the job:

• Education: Minimum four year degree in Science Engineering or other relevant technical discipline (e.g. BS/MS Biology Microbiology Pharmacy Chemistry Chemical Engineering or equivalent preferred).

• Minimum of 5 years relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements

Essential skills and competencies for this role:

• Ability to work on own initiative within minimum direction as well as lead/participate in cross-functional/matrixed teams and adapt to evolving business needs

• Ability to effectively collaborate and influence outcomes in line with business priorities

• Ability to problem solve solution and respond to complex problems/requests with minimum guidance and direction

• Demonstrates active listening skills as well as ability to compile and communicate information clearly

• Ability to work across boundaries demonstrates interpersonal relationship building and leadership skills

• Communicates in English both verbally and in writing

• Proficient with digital systems such as Veeva applications SAP COMET CLUE MS Teams

Required Skills:

Preferred Skills:

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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