Senior Specialist, GMP Operational Quality

Boston - USA

Monthly Salary: Not Disclosed

Posted on: 18-09-2025

Vacancies: 1 Vacancy

Job Summary

Job Description:

Developing Quality Documents.
Small Molecule Manufacturing.
The Senior Specialist is recognized as having a functional knowledge in the principles and application of quality assurance and regulatory compliance. The Senior Specialist ensures timely delivery of activities to support
developmental programs.
The Senior Specialist supports or executes a wide range of straightforward quality activities and supports new/existing project initiatives.
This role is responsible for the execution of Quality systems to support production and product advancement as well as the performance of product disposition of clinical products which includes drug substance drug
product intermediate (spray dried dispersion) bulk drug product and finished goods.
The Senior Specialist will demonstrate strong collaboration with key cross functional colleagues from Pharmaceutical Sciences CMC Regulatory GDP Finish Goods Supply Chain and R&D Quality to compliantly advance programs
through the product lifecycle.
The Senior Specialist work with CMC and Quality partners to ensure that compliance and business requirements are optimized.
The Senior Specialist will align with internal Quality functions Vendor
Management Inspection Readiness and Audit /Inspection Management to support all quality related activities associated with the programs.
The ideal candidate will possess a working knowledge of early phase to commercial GMP drug substance and drug product manufacturing regulations and good written and verbal communication skills. Prior Quality experience
supporting multiple projects and teams involved in drug development activities.

Responsibilities:

Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result associated with deviations OOS and OOT investigations ensuring appropriate CAPA actions are identified.
Supports change control assessments implementation and closure.
Identifies and facilitates continuous improvement efforts.
Supports drafting and revising Quality Agreements between CMOs/Suppliers and Company as needed.
Helps represent Company Quality on cross-functional working teams applying strong communication and collaboration skills.
Support continuous improvement projects.
Performs the review of executed batch documentation from external and/or internal manufacturing and testing (executed batch records release data in-process controls testing and stability data).
Use knowledge of functional area to inform decisions and support the success of batch disposition for drug substance drug product intermediate drug product and finished goods.
Supports GMP document review including certificate of analysis specifications.

Requirements:

Bachelors degree in a scientific or allied health field (or equivalent degree) and 2 years of relevant work experience or equivalent combination of education and experience.
Experience supporting multiple projects/teams within stated objectives and timelines.
Experience supporting cross-functional team members and collaborate effectively.
Good communication skills (written and verbal) and the ability to exchange potentially complex information.
Able to integrate activities with other groups departments and project teams as needed.
Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent.
Ability to work in a fast-paced environment and meet quality accuracy and timeliness objectives.
Expanded conceptual knowledge of cGMPs in a pharmaceutical setting.
Proficient in leading event investigations Root Cause Analysis (RCA) and CAPA.
Operational QA experience in analytical or manufacturing setting with experience in small molecule manufacturing.
Experience with biologics devices gene therapy a plus.
Practical GxP knowledge and understanding across lifecycle of the product including the application of:
GMP regulations and application to Manufacturing.
Root Cause Analysis methodology and tools.
Analytical techniques and data review.
Ability to evaluate routine quality matters and make decisions utilizing risk-based approach.
Ability to communicate cross-functionally to a wide variety of audiences.
Relationship management/conflict management skills.

Job Description: Developing Quality Documents. Small Molecule Manufacturing. The Senior Specialist is recognized as having a functional knowledge in the principles and application of quality assurance and regulatory compliance. The Senior Specialist ensures timely delivery of activities to support ...

Job Description:

Developing Quality Documents.
Small Molecule Manufacturing.
The Senior Specialist is recognized as having a functional knowledge in the principles and application of quality assurance and regulatory compliance. The Senior Specialist ensures timely delivery of activities to support
developmental programs.
The Senior Specialist supports or executes a wide range of straightforward quality activities and supports new/existing project initiatives.
This role is responsible for the execution of Quality systems to support production and product advancement as well as the performance of product disposition of clinical products which includes drug substance drug
product intermediate (spray dried dispersion) bulk drug product and finished goods.
The Senior Specialist will demonstrate strong collaboration with key cross functional colleagues from Pharmaceutical Sciences CMC Regulatory GDP Finish Goods Supply Chain and R&D Quality to compliantly advance programs
through the product lifecycle.
The Senior Specialist work with CMC and Quality partners to ensure that compliance and business requirements are optimized.
The Senior Specialist will align with internal Quality functions Vendor
Management Inspection Readiness and Audit /Inspection Management to support all quality related activities associated with the programs.
The ideal candidate will possess a working knowledge of early phase to commercial GMP drug substance and drug product manufacturing regulations and good written and verbal communication skills. Prior Quality experience
supporting multiple projects and teams involved in drug development activities.

Responsibilities:

Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result associated with deviations OOS and OOT investigations ensuring appropriate CAPA actions are identified.
Supports change control assessments implementation and closure.
Identifies and facilitates continuous improvement efforts.
Supports drafting and revising Quality Agreements between CMOs/Suppliers and Company as needed.
Helps represent Company Quality on cross-functional working teams applying strong communication and collaboration skills.
Support continuous improvement projects.
Performs the review of executed batch documentation from external and/or internal manufacturing and testing (executed batch records release data in-process controls testing and stability data).
Use knowledge of functional area to inform decisions and support the success of batch disposition for drug substance drug product intermediate drug product and finished goods.
Supports GMP document review including certificate of analysis specifications.

Requirements:

Bachelors degree in a scientific or allied health field (or equivalent degree) and 2 years of relevant work experience or equivalent combination of education and experience.
Experience supporting multiple projects/teams within stated objectives and timelines.
Experience supporting cross-functional team members and collaborate effectively.
Good communication skills (written and verbal) and the ability to exchange potentially complex information.
Able to integrate activities with other groups departments and project teams as needed.
Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent.
Ability to work in a fast-paced environment and meet quality accuracy and timeliness objectives.
Expanded conceptual knowledge of cGMPs in a pharmaceutical setting.
Proficient in leading event investigations Root Cause Analysis (RCA) and CAPA.
Operational QA experience in analytical or manufacturing setting with experience in small molecule manufacturing.
Experience with biologics devices gene therapy a plus.
Practical GxP knowledge and understanding across lifecycle of the product including the application of:
GMP regulations and application to Manufacturing.
Root Cause Analysis methodology and tools.
Analytical techniques and data review.
Ability to evaluate routine quality matters and make decisions utilizing risk-based approach.
Ability to communicate cross-functionally to a wide variety of audiences.
Relationship management/conflict management skills.