Director/Senior Director Quality Assurance - Stamford area, CT | Biospace
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Director/Senior Director Quality Assurance

Omega Management Group

Location:
Stamford area, CT
Posted Date:
6/19/2017
Position Type:
Full time
Job Code:
4810
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Director/Senior Director, Quality Assurance  
Job Details:
GENERAL DESCRIPTION/FUNCTION:
 

DUTIES & RESPONSIBLITIES:  

•   Responsible for the Quality Systems supporting the pre-clinical research/process development, clinical and commercial manufacturing
•   Ensure current Good Manufacturing Practices (cGMPs) compliance
•   Oversee the Quality System Operations & Continuous Improvement, QA and Document Control groups, including outlining strategic objectives, identifying process improvement, monitoring progress of deliverables, and providing support to the group Managers and Supervisors. Ensure the effective management of core Quality Systems such as change control, internal audit program, training, deviations, CAPA, supplier quality and risk management.
•   Direct QA support and work closely with contract service providers
•   Take the lead in developing and implementing procedures, programs and policies that support
GMP operations (training program, document control, materials handling, vendor audits, change control,
CAPA, etc.).
•   Develop risk assessments using a variety of tools such as FMEA and report areas of risk to Sr. Management ….
•   Serve as team leader in quality investigations and ensure corrective and/or preventative action plans to resolve potential product quality issues are appropriately implemented
•   Develop, negotiate and maintain Quality Agreements with Clients
•   Serve as site liaison for external client or regulatory audits, coordinating audit support, performing facility tours, answering questions and resolving issues. Respond to observations to ensure compliance risks are effectively mitigated
•   Responsible for supervision of designated staff to ensure effective execution of roles and responsibilities
•   Participate in facility expansion, coordinating QA support.



Requirements

SKILLS & TECHNICAL EXPERTISE:  

·       In depth knowledge of Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, the USP, ICH Guidelines and industry best practices. EU GMPs a plus.
·       Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish. Exposure to contract manufacturing a plus.
·       Ability to quickly learn new and novel manufacturing processes supporting new clients
·       Ability to self-direct, and adapt to changing priorities
·       Excellent communication and interpersonal skills required
·       Strong attention to detail and organization skills required
·       Proven technical writing and editing skills
·       Creative individual with excellent problem solving and trouble shooting skills
·       Requires the ability to produce results in a fast-paced environment to meet client deadlines
·       Established leadership capabilities

EDUCATION & PREVIOUS EXPERIENCE:

·       B.S. in a Life Sciences discipline and 10+ years of relevant experience – OR –
·       M.S. in a Life Sciences discipline and 8+ years of relevant experience
·       Experience within the life sciences industry, preferably biotechnology or pharmaceuticals, however medical devices is acceptable as well, performing within a Quality Assurance role at least 7 years, and prior management experience.
·       ASQ certification preferred.