Senior Quality Assurance Manager

Overview: 

This position is responsible for all aspects of Quality Assurance related to the facilities, QC activities, manufacturing activities, including the review and approval of Master and Executed Batch Records, test reports, specifications, raw materials, finished products and labeling, and any other controlled documentation for GMP manufacturing activities. 

Responsibilities:

·      A critical part of this position is the timely Quality Assurance review of documentation pertaining to

manufactured batches, supporting disposition of products and activities.

·      Another critical activity within this position is the timely Quality Assurance review of documentation pertaining as

defined in the Quality Management System.

·      The position is also responsible for revising and approving all controlled GMP Documentation. The position

reviews all of these documents for completion, accuracy and compliance with policies and procedures, and works

with responsible parties to resolve any issues.

·      The employee also reviews laboratory and analytical data, equipment validation, maintenance and calibration

records, including protocols, certifications and reports. The position reviews deviations and CAPAs generated

during GMP activities, and works with responsible parties to ensure timely completion.

·      Other responsibilities for this position include ensuring all training records are complete for all employees

involved in these GMP activities to ensure compliance with cGMP regulations and internal procedures.

·      Responsible for leading internal and external compliance audits. Lead or co-lead for FDA/regulatory audits.

· Prepare site audit responses by collaborating with site SMEs and department heads; oversee timely completion

of commitments. 

·  Auditing suppliers through surveys and on-site. 

·  Preparing audit reports; auditing scheduling and coordination. 

·      This position also has direct reports in the form of Shop Floor QA associates.

·   Author/compile on-demand, monthly, quarterly and annual summaries and metrics associated with compliance

activities. 

·  Provide support for Field Alert and Recall activities initiated by site or Customer.

·  Provide direction and oversight during active processes and apply understanding of FDA regulations (21 CFR 11,

21 CFR 820), FDA Quality Systems and Continuous improvement. 

·      The responsibilities of this position may be expanded to meet evolving Quality and Compliance needs, provided

adequate training for these responsibilities is documented.

·      This position reports to the VP of Quality.

Qualifications:  

Education/Experience:

·  Bachelor’s Degree in Science preferred (Chemistry, Microbiology or Biology preferred); however, relevant years of

experience will be considered. 

·     Master’s degree in chemistry, biochemistry (Preferred).

·  A minimum of 5-10 years’ experience and/or training and/or equivalent combination of education and

experience in the QA pharmaceutical industries. 

·  Prior experience working with aseptic manufacturing preferred. 

·  Prior experience interpreting DEA regulations. 

·     Experience leading internal/external audits.

·      Experience being the main point of contact for FDA/Regulator audits.

Physical Requirements:

·      Employee may be required to lift or handle objects not more than 50 pounds to perform certain duties essential

to the job function

·      Performance of tasks essential to the job function may require the employee to work directly with, handle, or

otherwise come into contact with chemicals or pharmaceutical agents (including potent compounds)

Training:

·      Must successfully complete all departmental training modules and meet the requirements as part of ongoing

training.

·      Must successfully complete all material handling training/verification as part of ongoing training.