Amy Blackwell
Quality Compliance Senior Manager @Glenmark Pharmaceuticals
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WORK HISTORY
Quality Compliance Senior Manager @Glenmark Pharmaceuticals
Monroe, NC, US
Responsible for implementing and managing the systems related to GxP compliance which includes, but is not limited to, the following systems: Supplier Management, Internal and External Audits, Electronic Quality Management Systems, Customer Complaints, Adverse Events, Product Recall, Field Alerts and Regulatory Surveillance. Support audits / inspection processes, including, but not limited to: governmental, regulatory, Corporate or vendor audits and audit readiness related activities.
EDUCATION
UNC Pembroke
Bachelor of Science (B.S.)
ABOUT AMY BLACKWELL
I am an accomplished, dedicated, and goal-oriented professional with extensive leadership experience within compliance/quality with robust knowledge and expertise in the pharmaceutical manufacturing industry. My mission is to join a team where my expertise can be utilized to drive the company to be superior in their field, surpassing its competition in meeting regulatory requirements and product quality. I am committed to driving excellence in processes, compliance, and continuous improvement.One of my strengths is the ability to communicate effectively with all levels within the company. I have a keen eye for detail and a passion for building collaborative, high-performance teams to implement robust quality systems and proactive problem-solving strategies that mitigate risks and enhance operational efficiency. I am focused on fostering a culture of quality and accountability, delivering measurable improvements that strengthen customer satisfaction, regulatory compliance, and sustainable business growth.My key proficiencies include- cGMP Auditing with worldwide regulations (FDA, MHRA, Canada, Japan, ISO Standards, etc.)- Corrective and Preventative Actions- Process Improvements- Change Control - Document Control- Cross Functional Communication - Employee Training- Customer Satisfaction- Investigations
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