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.
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 performance-based bonus eligibility.
We currently have two positions available in Cary, NC.
Director, Supply Chain and Supplier Relations
Position Overview:
This position contributes to the Company’s success in primarily overseeing the supply chain of the Company’s product portfolio through supplier management, sales and operations planning, sourcing and procurement, budgeting, capacity planning and project management. Since the Company does not conduct its own manufacturing, selection and management of CDMO partners is essential.
Summary of Key Responsibilities:
- Manage relationships with CDMO partners through site visits, weekly teleconferences, contract review and negotiations and acting as project lead;
- Sales and Operations Planning: Update and monitor sales forecast with input from Sales and Marketing departments; develop and communicate a production plan and ensure its execution from CDMO partners;
- Engage with the Associate Director, Supply Chain, Inventory & Logistics to ensure execution of production plan, timely delivery, inventory control and no out-of-stocks;
- Accountable for creating, defending, executing and overseeing annual departmental and COGS budgets;
- Liaise with CDMOs to ensure sufficient production capacity planning to meet long-term forecast;
- Act as project lead/relationship manager on any special projects involving CDMO partners;
- Lead cross-functional meetings to drive execution on Company and departmental strategic objectives relevant to supply chain;
- Present monthly KPIs to Management Team involving problem-solving and decision-making on all departmental activities relating to supply chain.
Required Qualifications and Skills:
- BA / BS in life sciences discipline, operations or business management
- 7- 10 years’ experience in supply chain within the pharmaceutical industry
- Supplier and contract management experience required
- Strong written and verbal communication skills, with the ability to interact effective at all levels
- Hands-on leader, with the willingness to “roll up his / her sleeves” to get the job done
- Ability to work effectively across different functions and locations
- Strategic and operational thinker, with the ability to drive scalable business growth
- Flexibility to adapt to changing priorities and manage activities to meet the needs of the business while maintaining a focus on quality
- Proficiency in MS Office (Outlook, Word, Excel, PowerPoint) and Adobe Pro
- Travel Requirements: Approximately 15% (both domestic and international)
Please submit your resume and cover letter to: careers@veloxis.com.
Director, Quality Control
Position Overview:
This position contributes to the Company’s success by providing analytical expertise in representing the Company’s Quality Assurance / Quality Control function on project teams. The incumbent will also ensure that the Company and its contractors operate under the quality standards necessary to meet FDA compliance and cGxPs while meeting the Company’s objectives. This will be achieved through overseeing product release at the Company’s third-party manufacturers, packagers and labs, and improving upon the Company’s internal quality systems.
Summary of Key Responsibilities:
- Provide technical review support of analytical discipline through data trending, managing stability product stability programs, and review of any OOS/OOTs;
- Review and approve vendor laboratory investigations, working within project teams and interacting with internal and external customers;
- Develop analytical protocols and support the execution of analytical activities to completion;
- Oversee and contribute to the batch release function for cGMP commercial manufacturing, analytical and distribution activities from the contract facilities. This role will be part of the final authority for product release to market;
- Responsible for the development, management, harmonization and improvement of the Company’s quality systems and procedures to ensure compliance with all applicable laws, regulations and quality standards in support of cGxP activities;
- Oversee and contribute in the timely execution and continuous improvement of all aspects of the quality processes, both internally and at the Company’s contract sites, including batch record review, analytical review, change control, deviations, investigations, complaints and CAPAs;
- Together with the Sr. Director, Quality Assurance, provide quality oversight of any manufacturing process changes, validations, specification changes, technology transfers, new product acquisitions, etc.;
- Review and offer Quality oversight in investigator-initiated study requests and promotion material review;
- Together with the Sr. Director, Quality Assurance, provide accountability for the qualification, maintenance and audit of global GxP suppliers;
- Develop and report on KPIs for functional areas that reflect department accountability and continuous process improvements;
- Together with the Sr. Director, Quality Assurance, act as co-lead for all regulatory inspections;
- This is a “hands on” position with no direct report. The incumbent will need to roll up his/her sleeves and contribute to the team’s success.
Required Qualifications and Skills:
- Bachelor’s Degree in a scientific/technical discipline; Master’s Degree in a scientific/technical discipline preferred;
- 15+ years’ experience in the biotechnology / biopharmaceutical / pharmaceutical industry with commercial pharmaceutical products intended for human use;
- 12+ years’ experience working in progressively responsible positions in Quality;
- Strong experience interacting with regulatory agencies (e.g., FDA, EMA);
- Thorough understanding of GMP, including 21 CFR 210 and 211, EU regulations, ICH guidelines and FDA requirements for pharmaceuticals;
- Solid experience in final closure review of deviation / non-conformance investigations, including analytical and batch disposition determination;
- Solid experience working with CMOs, contract test laboratories and packaging / labeling;
- Exceptional organizational skills; written and verbal communication skills; and analytical 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 AdobePro
- Travel Requirements: Approximately 25% (both domestic and international)
Please submit your resume and cover letter to: careers@veloxis.com.
Equal Opportunity Employer
Veloxis 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, protected veteran status or disability status.