Manager, Quality Assurance

Location
MD
Posted
Sep 06, 2019
Ref
1838
Hotbed
BioCapital
Required Education
Masters Degree/MBA
Position Type
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

Paragon Gene Therapy, in Gaithersburg, Rockville, Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses.

This role is responsible for overseeing the QA Client Services and Operations function. QA Client Services and Operations includes; managing clinical manufacturing projects for the QA department, oversees the batch disposition function, incoming material and product specifications, responsible for assessing quality related issues, and ensuring compliance with applicable regulatory and industry standards for phase appropriate GMP manufacture of biological products.

Key Responsibilities include, but are not limited to:

• Ensure current Good Manufacturing Practices (cGMPs) compliance for clinical manufacturing of phase I/II/III investigational biological product, and compliance to 21 CFR Parts 210, 211 and 600 as applicable.

• Work with management to initiate new client projects and support providing QA costs (labor, testing, etc.).

• Execute objectives, identifying continuous improvement initiatives, monitors progress of deliverables, and provides support to Sr. Management and Associates.

• Provides oversight and scheduling of QA Operations to ensure quality objectives are attained related to client projects and internal projects.

• Directs the batch record review and lot disposition activities, including raw materials, to ensure release of lots within prescribed timelines and in compliance with applicable regulatory submissions and approvals

• Facilitates QA support and works closely with other Paragon functional units including Manufacturing, Validation, Facilities Engineering, Pre-Clinical and Quality Control to assess and resolve quality issues with regards to the facility and products manufactured.

• Develops and implements procedures, programs and policies that support GMP operations

• Serve as team leader in quality investigations and ensure corrective and/or preventative action plans to resolve potential product quality issues are appropriately implemented

• Oversees QA Client liaison for hosting routine client audits. This includes coordinating audit support, performing facility tours, answering questions and resolving issues. Ensures response to observations in a timely manner and ensures compliance risks are effectively mitigated

• Participate in the Quality Metric review process, assess data for adverse trends, develop solutions and oversee implementation

• Responsible for supervision of designated staff to ensure effective execution of roles and responsibilities

• Responsible for staffing and overseeing training, professional development of employees and conducting performance reviews within group

• Participate in facility expansion projects, coordinating QA support.

• Continuous reviews of all systems and procedures (SOPs) for efficiency and regulatory compliance improvements.

Experience & Education:

• B.S. in a Science or Engineering field

• 10+ years of experience within the life sciences industry, preferably biotechnology or pharmaceuticals with 6 of those years in a Quality Assurance role

• 4+ years of direct management experience

• Thorough knowledge of cGMP regulations, quality systems and regulatory requirements

• Proficiency with electronic management systems (such as QDMS, LMS, EDMS, and E-Doc)

• Advanced skills with MS Office applications and Adobe Acrobat

• Experience supporting Federal government contracts is a plus

Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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