Associate Manager/Manager, Quality Assurance

Description

*This is an Onsite Role**

The QA Manager ensures compliance with cGMP and internal policies, procedures and specifications. This position is responsible for performing documentation for all quality system functions in accordance with cGMP and related company SOP’s, state, federal and local laws as applicable. This person should be knowledgeable of cGMP requirements, FDA regulations and ICH guidelines.

• The person will be responsible for managing and ensuring that facility meets all GMP, FDA and SOP requirements.
• Managing all quality operations to include inspection of components, bulk, and final products for the Chantilly, VA, ensuring release lead times are met with timely product disposition.
• Ensure that the facility is meeting all training requirements.
• Lead the communication of open quality document notification and resolution between all departments regarding Complaints, Investigations, Change Control, CAPA’s (including verification of CAPA’s) and other quality documents as needed.
• Manage and maintain audit inspections (Internal and External) for the site.
• Responsible for supporting the preparation, review, processing, and approval of various validation documents as application for the Granules, Chantilly, facility.
• Provide QA support, review and approval for relevant documents including relevant procedures, batch records, specifications, stability reports, technical reports (i.e., Qualification, Validation, Transportation.), trend reports, Annual Product Quality Reviews and other documents as needed.
• Responsible for performance and development of all Quality Assurance staff through mentoring and focusing on personal and professional growth.
• Work with Quality leadership team for proactive succession planning and a high-performance culture through people.
• Guide and lead by setting realistic personal goals for staff and provide regularly scheduled feedback throughout the year.
• Provide the means for incorporating the necessary tools, equipment, and methods into the new and existing processes aimed at continuous improvement.
• Implementation Quality management system tools and their compliance.
• Development and execution of quality training modules for the organization.
• Ensure staff receives appropriate knowledge and skill development and growth opportunities
• Work with Regulatory Affairs to supply information needed for FDA filings.
• Other duties as assigned by management.

Requirements

Knowledge & Skills

· Expert-level knowledge of the FDA guidance for Industry, Title 21 of the Code of Federal Regulations and Compendia (USP/EP/BP/etc...)

· cGMP compliance within the pharmaceutical manufacturing industry.

· Writing and maintaining cGMP documentation.

· Analyze data/information and resolve complex issues.

· Verbal and written communication skills.

· Work and communicate with cross-functional teams.

· Multiple priorities and re-prioritize tasks.

· Strong computer skills and working knowledge of Microsoft Office Suite and Adobe

· Demonstrated ability to work on complex assignments in collaboration with various departments.

Experience & Education

· Bachelor's degree in the life sciences (or equivalent work experience) minimum of 6+ years in a QA role within the pharmaceutical industry

· Master’s degree with 4+ years of pharmaceutical manufacturing experience and at least 3 years of those years in a progressive challenging QA department in the pharmaceutical industry.

Physical Requirements/Working Environment

· While performing the duties of this job, the employee is regularly required to, stand, sit, talk, hear, and use hands and fingers to operate a computer and telephone keyboard.

· Specific vision abilities required by this job include close vision requirements due to computer work.

· Ability to sit at a computer terminal for an extended period of time.

· Light to moderate lifting up to 10-15 lbs is required.

· Ability to work in a confined area