Quality Manager
- Employer
- PNEUMA RESPIRATORY
- Location
- Boone, NC
- Start date
- Aug 25, 2019
- Closing date
- Sep 23, 2019
View more
- Category
- Biotechnology, Healthcare, Management
- Job Type
- Employee
- Employment Status
- Full Time
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Job Purpose: This position contributes to the Company’s success by managing the cGMP quality systems required to monitor the quality of third-party contract manufacturing organizations (CMOs) throughout the entire product lifecycle.
Top Reasons to Work for Us
1. Competitive Salary
2. Company pays 100% of health insurance
3. Stock option grants
4. Help build life changing technology
Required Qualifications and Skills:
- Bachelor's degree in scientific / technical discipline
- 3+ years’ experience in the Biotechnology / Biopharmaceutical / Pharmaceutical industry with pharmaceutical or medical device products intended for human use
- 5+ years’ experience working in progressively responsible positions in Quality Assurance, including final closure review of deviation / non-conformance investigations and batch disposition determination
- Experience interfacing with regulatory agencies (g., FDA)
- Strong analytical experience preferred
- Strong understanding of GMP, including 21 CFR 210 and 211, ICH guidelines and FDA requirements for pharmaceuticals
- Experience with CMO, CTL and packaging / labeling
- Strong organizational skills, conscientious in attending to detail
- Excellent written and verbal communication skills
- Demonstrated analysis and problem-solving skills
- Ability to work in a dynamic, fast-paced environment with shifting priorities
- Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro
Summary of Key Responsibilities:
- Manage all aspects of quality systems, such as change control, deviations, investigations, complaints and CAPA systems to assure compliance and timely and accurate completion of reported events
- Manage Company's Quality Compliance in maintenance of site training, supplier management, internal audits and related functions
- Contribute to the development, management, harmonization and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations and Company quality standards in support of cGxP activities
- Manage the QA batch release function for cGMP commercial manufacturing and distribution activities from the CMO facilities
- Contribute to preparation and/or review of annual product review and updates for regulatory filings, batch release metrics and department reporting, as applicable
- Participate in cross-functional teams in preparation for regulatory inspections, quality and technical agreements, internal and external auditing, validation activities and special projects
- Prepare and/or review controlled documents (g., SOPs) required for compliance
Other duties as assigned by manager
Job Type: Full-time
Experience:
- Biotechnology / Medical Device / Pharmaceutical industry: 7 years (Preferred)
- Quality Assurance: 5 years (Required)
Work authorization:
- United States (Required)
Reply to: jobs@pneumarespiratory.com
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