Quality Assurance Manager Pharmaceuticals
As the Quality Assurance Manager Pharmaceuticals, you will oversee programs that maintain the purity of our sterile injectable pharmaceuticals. Your expertise will be vital in compounding these medicines, conducting essential microbiological testing, and ensuring compliance with regulatory standards. This position requires skillful navigation of the legal landscape while prioritizing the production of high-quality products. As a leader within the QA department, you will be responsible for managing the team’s duties, projects, and overall operations.
Quality Assurance Manager Responsibilities
- As a manager, providing guidance and mentorship to the QA team to help them grow and develop professionally is essential. The manager enhances their staff’s skills to help them become organizational contributors.
- Demonstrate proficiency in making QA decisions for Sterility Assurance, including manufacturing, facility design, maintenance, investigations, documentation, CAPA, change control, and regulatory compliance.
- Ensure timely creation and completion of QA documents, supported by standardized documentation, for deviations, investigations, CAPAs, change controls, and SOPs.
- Establishing effective standard operating procedures (SOPs) and providing appropriate training to ensure adherence to company standards is essential.
- Safeguard consistency of Company quality benchmarks for Sterility Assurance across all sites.
- Ensuring pharmaceutical integrity requires adherence to cGMP guidelines and relevant state and federal regulations. We must maintain compliance to guarantee the safety and efficacy of our products.
- Present weekly/monthly reports and analyze metrics and trends for continuous improvement.
- Spearhead developing and implementing corporate and site policies and procedures related to Sterility Assurance QA.
- To meet regulatory requirements, the Senior Manager QA must escalate concerns jeopardizing manufacturing and secure product release to the VP of Quality.
- Appropriate personnel policies and procedures are essential to create a positive work environment. Personnel policies must be enforced to ensure that all employees are treated fairly and respectfully.
- Perform other assigned responsibilities as directed.
The Quality Assurance Manager ensures our pharmaceutical products’ safety, efficacy, and quality while adhering to regulatory compliance requirements.
Required Skills and Attributes of Quality Assurance Manager
- Exceptional leadership and management skills
- Performance and goal-driven with experience implementing quality metrics that result in improved performance
- Must be customer-focused and possess a continuous improvement mindset
- Strong written and verbal communication skills
- Demonstrated ability to interact and collaborate with all company employees and customers
- Build trust, value others, communicate effectively, drive execution, foster innovation, focus on the customer, collaborate with others, solve problems creatively, and demonstrate high integrity.
- Proactively establish and maintain effective working team relationships with all support departments.
- Maintain professional internal and external relationships that meet company core values.
Education & Experience
- Bachelor’s Degree required
- Minimum 5 years experience as a Quality Engineer, Manufacturing Engineer, or Process Engineer
- Quality certifications or Lean Six Sigma Black Belt preferred
- Minimum 3 years of proven leadership and management experience
- Experience in the pharmaceutical industry is required
- Occasional travel may be required
- $180,000 – $205,900 Per Year
- Full Benefits
- Relocation assistance is available
Washington, New Jersey
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