Quality Project Manager
Company: Gables Search Group
Posted on: July 12, 2021
The primary purpose of this
position is to provide Quality Project Management support and
leadership to ensure accurate and timely submissions and responses
to regulatory agencies for new and transferred products. This
individual is expected to apply their technical knowledge and
communication skills to facilitate collaboration across multiple
departments within multiple sites. This individual will also
review and evaluate scientific, analytical and technical data as it
pertains to product testing and manufacture in support of
regulatory submissions. This person should be able to work
independently and in groups to identify and solve complex
- Develop, organize and manage
document tracking for the facilitation of Regulatory
- Lead cross-functional meetings
and discussions for the timely collection of documents for
- Evaluate, review and approve
relevant submission documents.
- Identify problems and provide
technical/analytical/scientific leadership for problem
- Promote collaboration and
communication between multiple departments within multiple
- Maintain awareness of
requirements for USP, FDA, ICH, WHO and other international
- Hands on participant in all
stages of product lifecycle.
- Act as central Quality contact
between Head Office and Site.
- Comply with applicable FDA and
international regulatory laws/standards and the Code of
- Maintain knowledge of current
regulatory requirements and standards as they pertain to documents
required for submissions.
- Represent company as appropriate
in FDA, notified body, internal and other regulatory
- Identify areas for improvement
and provide leadership for solutions.
- Develop, facilitate or request
required documents and provide to key stakeholders in organized
- Evaluate and continuously
improve systems, quality and compliance with regulatory
requirements, best practices and quality systems
- Be proactive with regulatory and
KNOWLEDGE, SKILLS, AND ABILITIES:
- A minimum of a Bachelor’s degree
in Science or Engineering or associated field is
- A minimum of 2 years or more of
experience in a Pharmaceutical environment, including experience
with regulatory audits.
- Strong understanding of Good
Manufacturing Practices (GMP), Good Laboratory Practices (GLP),
Good Documentation Practices (GDP), USP and ICH
- Strong documentation skills are
required, including writing SOPs, technical papers and
- Proficiency with Microsoft Word,
Microsoft Excel and Power Point are required. Excellent typing
skills are required.
- Strong organizational and
communicative skills are imperative.
- The ability to work
independently and within a team structure and on multiple projects,
with flexibility to adapt to changing priorities is required. This
candidate must be a technical expert and have excellent written and
oral communication as well as interpersonal relationship
Keywords: Gables Search Group, Rock Hill , Quality Project Manager, Other , Monroe, South Carolina
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