Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, passionate people who thrive in a collaborative team environment.
If you’re looking to make a significant difference with a patient-centric company, then we invite you to learn more about the opportunities available at Veloxis.
We currently have a Manager, Quality Assurance position available in Cary, NC.
Purpose and Scope:
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 life cycle.
Summary of Key Responsibilities:
- Contributes 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
- Assists with 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
- Assists the Company’s Quality Compliance and Site Head of Quality in maintenance of site training, supplier management, internal audits and related functions
- Manages the QA batch release function for cGMP commercial manufacturing and distribution activities from the CMO facilities
- Contributes to the preparation and / or review of annual product review and updates for regulatory filings, batch release metrics and department reporting, as applicable
- Participates in cross-functional teams in preparation for regulatory inspections, quality and technical agreements, internal and external auditing, validation activities and special projects
- Prepares and / or reviews controlled documents (e.g., SOPs) required for compliance
- Other duties as assigned by manager
Required Qualifications and Skills:
- Bachelor’s Degree in a scientific / technical discipline
- Minimum of 7 years’ experience in the biotechnology / biopharmaceutical / pharmaceutical industry with pharmaceutical products intended for human use
- 5+ years’ experience working in progressively responsible positions in quality
- Experience interfacing with regulatory agencies (e.g., FDA)
- Strong understanding of GMP, including 21 CFR 210 & 211, ICH guidelines and FDA requirements for pharmaceuticals
- Quality assurance experience, including final closure review of deviation / non-conformance investigations and batch disposition determination
- Experience with CMO, CTL and packaging / labeling
- Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro
- Strong analytical and organizational skills
- Excellent written, verbal and interpersonal communication skills
- Ability to professionally interface with senior-level executives, staff, external partners and consultants
- Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment
- Ability to take initiative, prioritize and execute tasks and special projects with minimal direction or supervision, maintaining a high-level of confidentiality, integrity and discretion at all times
- Travel Requirements: Approximately 15% (both national and international)
Please email your cover letter and current resume to firstname.lastname@example.org
Compensation and Benefits
Our success is tied to the contribution of every team member, which is why we provide a valuable, competitive compensation package that includes health and insurance benefits, training and development opportunities, as well as stock warrant grants and performance-based bonus eligibility.
Equal Opportunity Employer
Veloxis Pharmaceuticals, Inc. is an Equal Opportunity / Affirmative Action employer, and will consider all qualified applicants for employment with regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.