Manager, QA Operations (QP)

PTC Therapeutics; United States; Remote; USD 95,000 - 130,000; Full time

Job summary

PTC Therapeutics is seeking a Manager, Quality Operations, Qualified Person (QP) to ensure compliance with regulatory standards for clinical and commercial products. The role involves routine certification of products, QA reviews, and enhancing quality systems in a biopharmaceutical setting. Ideal candidates will have significant experience in QA/QC and hold a scientific degree.

Qualifications

• Minimum of 6 years relevant experience in pharmaceutical Quality Assurance (QA)/Quality Control (QC)/Compliance roles.
• QP status as defined by Directive 2001/83/EC.
• Demonstrated proficiency in application of QA principles and industry practices.

Responsibilities

• Performs the routine duties of the QP and certifies batches for release within the European Community.
• Conducts QA review and approval of documentation related to small molecule contract manufacturing.
• Supports improvements to the PTC quality systems and GMP practices.

Skills

Analytical thinking

Problem-solving skills

Planning and organization

Education

Bachelor’s degree in a scientific discipline

Job description

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture!
Site: www.ptcbio.com

Job Description Summary: PTC is an established global biopharmaceutical company that delivers transformative therapies for people living with rare diseases. For over 25 years, we have been harnessing our scientific platforms to create new therapies that address the underlying cause of the disease and deliver on our promise to create more moments for those who count on us.

The Manager, Quality Operations, Qualified Person (QP) is responsible for the QP Certification of PTC clinical and commercial products as per PTC Therapeutics International Limited’s MIA and MIA(IMP)on behalf of PTC Therapeutics. The incumbent ensures all batches comply with the requirements of the Marketing Authorization, Investigational New Drug/Investigational Medicinal Product Dossier (IND/IMPD), as applicable, and have been manufactured and tested according to the principles of current Good Manufacturing Practice (cGMP) as per the relevant EU and FDA requirements. He/she supports the activities of the Quality Wholesale Dealer Authorisation and Manufacturing Authorisation. He/she 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, Chemistry, Manufacturing and Control (CMC), Regulatory Affairs, and supporting Contract Manufacturing Organizations (CMOs), Contract Testing Labs, Distribution partners 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. Job Description:

Responsibilities of the role include:

• Performs the routine duties of the QP and certifies batches for release within the European Community in accordance with the relevant EC Directives including 2001/83/EC, Eudralex Vol 4 including Annex 16 and 13.
• Performs QA review and approval of documentation related to small molecule contract manufacturing, packaging, labeling, and analytical records, as well as other related documents as required by GMP 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 (bulk and finished) and packaging, including but not limited to: master batch records, executed batch records, investigations, change controls, and releases.
• Master plans, protocols, and reports associated with validation at PTC and CMOs, including process and analytical validation activities.
• Investigations, incidents, complaints, exceptions, deviations, and out of specification reports (OOS) as generated by CMOs.
• Laboratory methods and specifications for analytical procedures related to PTC API, drug product, and packaged material.
• Ensures that manufacturing and testing activities undertaken by CMOs/Contract Testing labs are conducted in compliance with GMP or equivalent.
• Approves, or rejects as required, any drug substance, bulk and finished drug product batch.
• Supports the Quality Department in relation to QP certification activities linked to PTC Therapeutics International Limited’s Manufacturing Authorisations.
• Ensures the successful submission of required paperwork, releases, and other related documents to PTC partners and government agencies both domestic and international for Clinical and Commercial product.
• Contributes to the management of the Change Control System by reviewing Change Control documents for Clinical and Commercial product.
• Provides QA operations support to Quality, Regulatory Affairs and CMC as required, in meeting regulatory compliance and corporate business requirements for Clinical and Commercial Supplies. This includes, but is not limited to:
  • Performs QA review/approval of documents to support regulatory submissions.
  • Performing QA review of CMC documentation, including reviewing and approving documented manufacturing, packaging and analytical records.
  • Performs QA review and approval of Master Batch Records
  • Completes Quality Approval of clinical and commercial labelling as per PTC procedures.
  • Provides Quality Operations input into the review of Quality Technical Agreements.
  • Assists in the implementation of quality systems pertaining to Clinical and Commercial product.
  • Reviewing SOPs related to GMPs.
• Liaises and effectively interfaces with internal and external peers in the execution of assigned functions and regulatory compliance for Clinical and Commercial Supplies.
• Supports improvements to the PTC quality systems and GMP practices by identifying and making recommendations for improvements to processes within the overall Continuous Improvement Process of the Company.
• Supports Regulatory Inspections by Competent Authorities as required at both PTC facilities or CMO’s as applicable. Supports the formulation of audit responses, as required.
• Performs GMP/GDP audits of CMOs, contract testing labs and distributors, as required.
• Completes all duties as per relevant procedures; ensures compliance to cGMP at all times.

• Performs other tasks and assignments as needed and specified by management.

Requirements for the role include:

• Experience working in a small but fast growing, entrepreneurial orphan, rare disease organization that launchings innovative therapies is preferred.
• Bachelor’s degree in a scientific discipline and a minimum of 6 years relevant experience in pharmaceutical Quality Assurance (QA)/Quality Control (QC)/Compliance roles

• QP status as defined by Directive 2001/83/EC relating to medicinal products for human use.
• Demonstrated proficiency in application of QA principles, concepts, industry practices, and standards.
• Excellent working knowledge of regulations and sources of regulatory information.
• Detailed knowledge and understanding of GMP and/or GCP regulations.
• Excellent understanding of production and laboratory systems to effect judgment decisions consistent with business needs.
• Demonstrated understanding of international quality systems regulations to adopt best in class systems/processes.
• 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.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

EEO Statement:

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.

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