Senior Specialist Small Molecule CMC Compliance
Posted 3 days ago by 1761640696
Negotiable
Undetermined
Remote
Boston, Massachusetts
Summary: The Senior Specialist in Small Molecule CMC Compliance will support Good Manufacturing Practices (GMP), Quality Assurance, and regulatory compliance within a biopharmaceutical company. This role involves coordinating Annual Product Reviews (APRs) and contributing to compliance and continuous improvement initiatives. The position is remote after training and is offered as a 6-month contract with potential for extension. The candidate will work closely with cross-functional teams to ensure quality and compliance standards are met.
Key Responsibilities:
- Coordinate the development and delivery of Annual Product Reviews (APRs) for all commercial products.
- Collaborate with subject matter experts (SMEs) to define scope, author content, and finalize APR documentation.
- Author key report sections such as Purpose, Executive Summary, and Conclusions.
- Identify appropriate Corrective and Preventive Actions (CAPAs) and ensure timely approval and archiving of reports.
- Support quarterly quality trending activities for commercial products manufactured internally and at Contract Manufacturing Organizations.
- Represent Quality in cross-functional working teams, applying strong communication and collaboration skills.
- Contribute to continuous improvement initiatives within the Quality organization.
Key Skills:
- Demonstrated experience facilitating and authoring APRs or Annual Product Quality Reviews for commercial pharmaceutical products.
- Proven ability to manage multiple projects and deliver within defined timelines.
- Effective collaboration and communication skills across cross-functional teams and stakeholders.
- Strong written and verbal communication skills, with the ability to convey complex information clearly.
- Working knowledge of current Good Manufacturing Practices (cGMPs) in a pharmaceutical environment.
- Proficiency in event investigations, Root Cause Analysis (RCA), and CAPA processes.
- Ability to thrive in a fast-paced environment while meeting quality and timeliness objectives.
Salary (Rate): £62.00 hourly
City: Boston
Country: United States
Working Arrangements: remote
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Senior Specialist, Small Molecule CMC Compliance
Boston, MA (remote after training)
Schedule:
Standard Office Hours
Duration:
6-Month Contract (with potential extension)
Pay:$62-67/hr
Our client is a global biopharmaceutical company dedicated to discovering, developing, and commercializing innovative therapies for serious diseases.
In this role, you will support the principles and application of Good Manufacturing Practices (GMP), Quality Assurance, and regulatory compliance within the Small Molecule CMC Compliance team. You will coordinate the delivery of Annual Product Reviews (APRs) and contribute to various compliance and continuous improvement initiatives.
Key Responsibilities:
- Coordinate the development and delivery of Annual Product Reviews (APRs) for all commercial products.
- Collaborate with subject matter experts (SMEs) to define scope, author content, and finalize APR documentation.
- Author key report sections such as Purpose, Executive Summary, and Conclusions.
- Identify appropriate Corrective and Preventive Actions (CAPAs) and ensure timely approval and archiving of reports.
- Support quarterly quality trending activities for commercial products manufactured internally and at Contract Manufacturing Organizations.
- Represent Quality in cross-functional working teams, applying strong communication and collaboration skills.
- Contribute to continuous improvement initiatives within the Quality organization.
Knowledge, Skills, and Competencies: - Demonstrated experience facilitating and authoring APRs or Annual Product Quality Reviews for commercial pharmaceutical products.
- Proven ability to manage multiple projects and deliver within defined timelines.
- Effective collaboration and communication skills across cross-functional teams and stakeholders.
- Strong written and verbal communication skills, with the ability to convey complex information clearly.
- Working knowledge of current Good Manufacturing Practices (cGMPs) in a pharmaceutical environment.
- Proficiency in event investigations, Root Cause Analysis (RCA), and CAPA processes.
- Ability to thrive in a fast-paced environment while meeting quality and timeliness objectives.
Preferred Experience: - APR and Veeva systems experience.
- Exposure to cross-functional environments with large stakeholder groups (30+).
Education & Experience: - Bachelor’s degree in a scientific or allied health field (or equivalent).
- Minimum of 2 years of relevant experience, or an equivalent combination of education and experience.
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