Description

Position Summary:

The Sr. Manager of Quality Assurance Compliance – Audits has primary responsibility for all activities related to cGMP audits including hosting regulatory, customer, certification audits and directing/conducting all 3rd party and internal audits. In addition, the position is responsible for managing the Document Control team and facility compliance to support audit functions.

Responsibilities: Responsibilities include, but are not limited to:

Audit Program:

· Plan and perform internal & external audits (raw material, printed and non-printed components, contract labs/manufacturers) against GMP regulations, or other appropriate regulations as standards.

· Oversee the Foreign Supplier Verification Program

· Establish audit teams with appropriate skill sets

· Report audit findings

· Evaluate corrective action plans and monitor completion

· Ensure audit schedule adherence

· Issue audit closure letters

· Schedule, host, and respond to regulatory, customer, and certification audits

· Coordinate audit documentation and personnel

Document Control:

· Approve SOPs and other cGMP documentation as needed.

· Master and Production Batch Record retention

· Release bulk and finished product to market

Facilities:

· Pest Control Program

· Environmental Monitoring Program

· Change Control Approval

· Equipment IQ/OQ

· Metrology

· Food Defense Plan and subject matter expert.

· Monitor facility metrics

Supplier/Contractor Qualification:

· Conduct Audits

· Maintain Qualified Supplier list

· Prepare and/or approve Annual Product reviews (APRs)

· Prepare and/or approve Customer, Contractor and Supplier Quality Agreements

Requirements

Education and Experience:

· Bachelor’s degree in science, compliance, or related required

· Master’s degree preferred

· 5 years of GMP managerial experience within pharmaceutical quality assurance and compliance.

· Minimum 2 years conducting and hosting GMP audits of pharmaceutical and/or supplement manufacturers.

· Preferred Certifications:

. Foreign Supplier Verification Program

.Preventative Controls for Human Food

.Preventing Intentional Adulteration of Human Food

.ASQ Certified Quality Auditor (CQA)

Skills, Abilities and Knowledge:

· US FDA and EU EMEA cGMPs for pharmaceutical and supplement manufacturing

· Pharmaceutical Quality Systems

· ICH, USP, and EP Guidance

· Analytical principles and manufacturing processes

· Validation study designs (e.g., method, cleaning, process)

· Data analysis

· Effective written and oral communication skills to all employee levels

· Knowledge of computer program validation principles

· Excellent technical writing skills and attention to detail

· Experience in auditing compliance (e.g. EU, FDA, GMPs)

· Ability to manage multiple tasks and meet deadlines

· Proficient in Microsoft Word, Excel, Power Point, Microsoft Office Outlook

· Required training in SOP, cGMP, and General Safety procedures

Physical Demands:

· Required to use hands to operate computer controls.

· Specific vision abilities required include close vision, ability to focus.

Work Environment:

· Required to be present in the office to collaborate with directors, peers and other departments daily.

· Responsible for adherence to safety policies.

· Flexible schedule to meet business requirements

Supervisory Responsibilities:

· Responsible for managing non-union employees

Salary Range: 

$90,000 - $120,000 per year