The Senior Specialist, Quality Operations - GMP supports the on-going enhancement of the PTC total quality system by managing Quality Assurance (QA) functions related to Good Manufacturing Practice (GMP) compliance for Clinical and Commercial products. This involves working with cross-functional internal teams; Chemical, Manufacturing and Control (CMC); Regulatory Affairs; and Contract Manufacturing Organizations (CMOs) to implement, manage, maintain, and support quality assurance activities, including plans that contribute to the PTC ability to achieve and maintain regulatory compliance and ensure product quality for Clinical and Commercial Supplies.
The incumbent works cross-functionally with internal departments and external resources on Quality related issues.
The Senior Specialist, Quality Operations - GMP supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Performs QA review and approval of documentation related to contract manufacturing, packaging, labeling, and analytical records, as well as, other related documents as required by regulation for Clinical and Commercial Supplies. This includes the review and approval of:
Manufacturing/packaging records for precursors, Active Pharmaceutical Ingredients (API), drug substance, drug product, and packaging, including but not limited to: master batch records, executed batch records, investigations, change orders, and releases;
Investigations, incidents, complaints, exceptions, deviations, and out of specification reports (OOS) as generated by CMOs;
Methods and specifications for analytical procedures related to PTC API, drug product, and packaged materials.
Ensures the successful submission of required paperwork, releases, and other related documents to PTC partners for Clinical and Commercial product.
Contributes to the management of the Change Control System by generating and reviewing Change Control documents for Clinical and Commercial product.
Resolves queries with CMOs in a timely manner, escalating issues to line management as required.
Provides QA support to Regulatory Affairs and CMC in meeting regulatory compliance and corporate business requirements for Clinical and Commercial Supplies. This includes, but may not be limited to:
Performing QA review of CMC documentation, including reviewing and approving documented manufacturing, packaging and analytical records.
Reviewing SOPs related to GMPs.
Liaises with, and effectively interfaces with, internal and external peers in the execution of assigned functions and regulatory compliance for Clinical and Commercial Supplies.
Recommends QA system changes to enhance overall job performance and QA functions pertaining to Clinical and Commercial product.
Maintains electronic and paper-based documentation, as needed.
Performs other tasks and assignments as needed and specified by management.
* Minimum level of education and years of relevant work experience.
Bachelor’s degree in a scientific discipline and a minimum 5 years of experience in QA or related role(s) in a pharmaceutical, biotechnology or related environment, at least 2 of which have been in a CMC-focused QA position.
* Special knowledge or skills needed and/or licenses or certificates required.
Detailed/Demonstrated knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements.
Demonstrated proficiency of commercial and clinical batch record review and experience of working with Contract Manufacturing organizations.
Experience with production and laboratory systems to effect judgment decisions consistent with business needs.
Experience in Quality Management Systems including Deviation Management, Out of Specifications, Change Control.
Proficiency with Microsoft Office.
Excellent verbal and written communication skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
*Special knowledge or skills and/or licenses or certificates preferred.
• Experience working directly with the FDA, as well as, external US regulatory authorities.
• Analytical lab experience.
• Validation/manufacturing experience.
* Travel requirements
0 - 15%
*Physical requirements (only note if the job requires physical capacity beyond general office work)
Office based position
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.