Job Posting Details


Summary

SUMMARY:

 

The Director of Quality Control/Assurance will be responsible for representing QA on SELLAS project teams and overseeing the GCP and GMP operations at contracted vendors in support of SELLAS’s programs. The individual will also be responsible for reviewing applicable data in support of Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), New Drug Applications (NDAs), Biological Licensing Applications (BLAs), and Marketing Authorization Applications (MAA). The ideal candidate will have a strong quality control/assurance / GMP and GCP operations background, experience with biologics, small molecules, and regulatory inspections. In addition, excellent verbal and written communications skills are required.

 

ESSENTIAL DUTIES/RESPONSIBILITIES:

 

The Director, Quality Control/Assurance will be responsible for assisting the Quality Control and Assurance Operations function to ensure clinical trial material is manufactured and tested according to cGMPs and that the clinical studies are conducted under cGCP and may lead audits as warranted. 

 

The Director, QC/QA will have the following responsibilities:

 

Review of executed batch records and disposition batches, certifying compliance with study, regulatory and GMP requirements.

Collaborate with SELLAS CMC and Technical Operations colleagues to ensure timely technical reviews of batch records

Review clinical data and perform or lead cGCP audits to assure successful regulatory submissions

Assist with review and approval of Master Batch Records & Packaging Records, etc.

Complete Batch Record review checklists for batch disposition

Generation of certificates of release and compliance, etc.

Work with CMOs and SELLAS CMC teams to assess investigations, and deviations and bring to closure in a compliant manner

Ensure timely implementation of corrective actions and escalate as necessary

Ensure products meet regulatory requirements

May perform document change control activities (i.e., SOP writing) as needed

Develop, revise, implement and adhere to Quality Control/Assurance department policies and procedures

Assist with maintaining file organization within the Quality department

Other duties as assigned

 

Education/Experience:  Bachelor's or Master's degree in Life Sciences field or equivalent, with 8+ years pharmaceutical/biotechnology industry experience and a minimum of 6 years in Quality Control/Assurance.

Previous biologics and small molecule drug and BLA/NDA-level experience are a strong plus.

Established working knowledge of cGCP and cGMP and other applicable regulations (US and international).

Quality Control/Assurance experience supporting both development projects and commercial products.

Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.

Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.

Strong communication skills both written and oral.

Ability to multi-task and shift priorities rapidly to meet tight deadlines.

Professional demeanor and an excellent written and verbal communicator both inside and outside the company.

Detail oriented and well organized.

Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.

Some travel required.



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