Senior Specialist Quality Assurance (one year contract)

Job Description

The In‑Market Quality Compliance Senior Specialist reports to the Quality & Compliance Director Distribution & In‑Market Quality (DIMQ).

The incumbent is responsible for ensuring compliance of Distribution & In‑Market Quality processes against approved quality manual documents and aiding in the assurance of robust business systems in compliance with Company policies.

The role is fixed term for one year and functions under the leadership of the Director of Compliance, but will work independently with minimal direction.

A key element of the role is to enhance existing business processes and/or quality systems and help identify and advance performance improvement activities.

Responsibilities

• Ensure Distribution & In‑Market Quality processes remain compliant with applicable GDP, GMP, medical device regulations, company standards, and global quality requirements.
• Support deployment and implementation of new or revised Quality Management System (QMS) policies, procedures, and standards.
• Help identify, drive, and implement continuous improvement initiatives that enhance quality performance and operational efficiency.
• Share learnings and best practices from internal and external quality audits to strengthen compliance across the organization.
• Support management reviews and governance forums, including Quality Council and QMS Council activities.
• Document, investigate, track, and report Product Quality Complaints, including coordination of PQC sample management.
• Contribute to customer qualification activities, product risk assessments, Annual Product Quality Reviews, and temperature excursion investigations as required.
• Participate in projects and business initiatives, providing quality guidance to ensure compliance, business continuity, and operational excellence.
• Monitor regulatory developments and industry trends, particularly those impacting pharmaceutical importation, distribution, and in‑market quality activities.
• Partner closely with Global Quality, External Manufacturing Quality, Supply Chain, Regulatory Affairs, Pharmacovigilance, Medical Affairs, and Quality units across the manufacturing network.
• Build strong relationships with key stakeholders to ensure alignment on quality priorities and compliance expectations.
• Provide guidance and expertise to colleagues within the DIMQ team on quality compliance and quality systems topics.

Qualifications

• Bachelor’s or Master’s degree in Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering or equivalent.
• Minimum five years of experience in the pharmaceutical industry with solid compliance experience.
• Expertise in Quality Systems, Quality Assurance, and Quality Control including solid knowledge of global GDP and regulatory requirements.
• Strong compliance mindset, excellent project management, organizational, and problem‑solving skills.
• Demonstrated ability to apply sound risk‑management principles in complex and evolving environments.
• Excellent communication, collaboration, and leadership skills in dealing with a broad variety of issues.
• Ability to work collaboratively across functions and within matrix organizations to achieve objectives.
• Additional Information

Fixed‑term program for one year.

EEO Statement

As an equal opportunity employer, we welcome applications from candidates with a diverse background.

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