Sr Mgr, Quality Assurance, GMP | BioNJ Talent Services

Sr Mgr, Quality Assurance, GMP

Contact Information
Contact Name: 
PTC Therapeutics
Organization Name: 
PTC Therapeutics
Position Location: 
South Plainfield
Company Profile: 

Translating Science. Transforming Lives.

Our mission at PTC Therapeutics has always been to build an integrated biopharmaceutical company based on our expertise in RNA biology. We have focused on discovering and developing novel oral treatments for patients with serious and life-limiting disorders. By targeting the processes that modulate RNA biology and affect protein production, we bring an innovative approach to drug discovery. We are focused particularly on the development and commercialization of treatments for rare and neglected disorders.

Commitment to Patients.

We are committed to finding treatment options for patients living with life-threatening diseases. Our lead product candidate is ataluren for the treatment of patients with genetic disorders due to a nonsense mutation. Ataluren is in clinical development for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). Ataluren has been approved under the trade name Translarna™ in the European Union for ambulatory patients with nmDMD who are 5 years and older.

Job Description:

JOB SUMMARY

The Senior Manager, Quality Assurance - 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 Manager, Quality Assurance - GMP supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Primary duties/responsibilities:
•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;
•Packaging and labeling, including changes in components, master copy, new labeling, etc.;
•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;
•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 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 support to Regulatory Affairs and CMC, in meeting regulatory compliance and corporate business requirements for Clinical and Commercial Supplies. This includes, but is not limited to:
•Performing QA review of CMC documentation, including reviewing and approving documented manufacturing, packaging and analytical records.
•Assisting 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.
•Recommends QA system changes to enhance overall job performance and QA functions pertaining to Clinical and Commercial product.
•Performs other tasks and assignments as needed and specified by management.

Qualifications: 

KNOWLEDGE/SKILLS/ REQUIRED
* Minimum level of education and years of relevant work experience.
Bachelor’s degree in a scientific discipline and a minimum 6 years of experience in QA or related role(s) in a pharmaceutical, biotechnology or related environment, minimum 3 years have been in a CMC-focused QA position.

Special knowledge or skills needed and/or licenses or certificates required.
•Detailed knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements.
•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%

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Quality Assurance