***Immigration sponsorship is not available for this role.  Relocation assistance is not available for this role.***

The Good Manufacturing Practice Quality Assurance (QA) Manager oversees, implements, and maintains cGMP compliant systems and activities. Incumbent is also responsible for evaluating internal controls and maintenance of cGMP documentation for compliance with quality and regulatory standards.  The GMP QA Manager also monitors Contract Manufacturing Organizations (CMOs) ensuring compliance of the manufacturing, packaging and analytical testing of pharmaceutical dosage forms and drug substances. They also identify risks and deficiencies, which they communicate to cross functional teams and management.

Essential Duties and Responsibilities:

Following is a summary of the essential functions for this job.  Other duties may be added and performed, which are not mentioned below.  Specific activities may change from time to time.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

·        Ensures cGMP analytical activities, such as analytical methods, test results and Certificates of Analysis (CoA), comply with internal SOPs, company policies and procedures, safety and environmental and regulatory requirements;

·        Reviews cGMP batch manufacturing and packaging records and provides recommendations for approval/rejection and disposition;

·        Manages and approves cGMP investigations, quality incidents, deviations, CAPAs, change control and out-of-specifications/out-of-trends (OOS/OOTs); follows up to verify effectiveness;

·        Assists with development and implementation of cGMP compliant systems, including internal SOPs, forms, and work instructions;

·        Performs Independent audits for compliance to policies and procedures: on paper vs. practice

·        Assists corporate quality group in preparation of internal quality audit programs and conducts internal audits per approved schedules in accordance with pertinent quality documents; prepares all corresponding documents and reports;  

·        Leads all external GMP audits of vendors, including European GMP vendor audits, as needed;

·        Coordinates annual and ongoing cGMP training;

·        Acts as a primary contact for GMP regulatory inspections;

·        Oversees release of commercial product;

·        Maintains the quality function for drug substances, drug products and clinical supplies, including but not limited to:

o    Releases or rejects all drug substances, drug products and clinical supplies;

o    Releases or rejects intermediates for use outside of the control of the manufacturing company;

o    Establishes a system to release or reject raw materials, intermediates, packaging and labeling materials;

o    Reviews unexecuted and completed batch production and laboratory control records of critical process steps before release of drug substances, drug products and clinical supplies for distribution;

o    Reviews and monitors release and stability data;

o    Reviews and approves changes that potentially impact quality of intermediates, drug substances, drug products and clinical supplies;

o    Reviews and approves validation protocols and reports, Specifications, certificates of analysis (CoAs), release of raw materials, and product disposition;

o    Approves selection of contract manufacturers for intermediates, drug substances, drug products and clinical supplies;

o    Approves all specifications and master production instructions;

o    Approves all procedures impacting the quality of intermediates, drug substances, drug products and clinical supplies;

o    Ensures effective systems are used for maintaining and calibrating critical equipment;

o    Ensures materials are appropriately tested and the results are reported;

o    Ensures there is stability data to support retest or expiry dates and storage conditions on drug substances, drug products, clinical supplies, and intermediates where appropriate; performs product quality reviews;

o    Develops with the CMC team and CMOs: drug substances (DSs), drug products (DPs), key raw material and intermediates specifications and stability requirements, master batch records, validated manufacturing processes and analytical methods, and CTM and commercial packaging and labeling.

Education/Experience:

•       BA or BS degree in a scientific discipline preferred, or comparable experience;
•       Auditing experience in a GMP and GCP environment;
•           Knowledge of US, EMA, and ICH regulations, guidance and industry standards for CMC, GMP and GCP;
•           5 + years in pharmaceutical Quality Assurance;
•       Previous experience of manufacturing and/or analytical testing is a plus;
•       Proficiency using Office 365, ChemDraw, Analyst, Watson LIMS, Adobe Acrobat (standard), ImgBurn, DYMO labeler, Adobe Acrobat (standard), and various internet browsers;
•          Ability to travel, including overnight.