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HR201:  Manager, Quality & Compliance Location: Bridgewater, NJ Company Description Nevakar is a privately held, specialty pharmaceutical company focused on developing innovative injectable and ophthalmic products. Our mission is to address unmet clinical and commercial needs by enhancing FDA-approved molecules through advanced formulation, functional packaging, and novel drug delivery strategies. We pursue value-driven product development, leveraging the 505(b)(2) regulatory pathway to bring meaningful improvements to patients and providers alike. Position Summary Incumbent will work with a cross functional team located in Bridgewater, NJ to lead and continuously improve GLP, GCP and GMP compliance of internal systems and global contractors / suppliers. The main focus of the position will be to ensure appropriate and well-maintained systems are in place to support the team with development, manufacturing, design controls, regulatory filings, and commercial launch of sterile drug / device combination products. Key accountabilities include ownership of the vendor qualification process, change control system, OOS and CAPA tracking, training program, support of DEA / NJ DEP compliance, as well as SOPs / metrics and coordination of Quality Steering Committee. Responsibilities: Supplier Qualification Process: Lead vendor qualification program. Lead approvals and revisions to Quality Agreements for CMOs / GMP Labs / CROs & API Suppliers. Document Managements System Prepare yearly budget in coordination with vendors System administrator for Master Control Training Program: Coordinate training program systems at the site Change Control System: Lead documentation exchange/approvals from external and internal teams in order to provide a high degree of assurance there are no unintended consequences when changes are made. Maintain/ Update documentation to ensure change control tracking and file system is compliant with internal SOPs and regulatory requirements.

• Facilitate Change Control meetings and update electronic databases as and when needed.
• Run reports and trend data for change control documents in order to support management review.

Combination Product Design Controls:

• Draft documents in coordination with the development team to assess user risks and manufacturing risks of drug / device combination products.

Quality Steering Committee:

• Coordinate the Quality Steering Committee and other quality boards on a routine basis.
• Lead collection of internal and external quality metrics which includes tracking, trending, and escalation of issues.

Compliance

• Lead preparations for regulatory inspections at the site.
• Perform routine oversight activities according to agree upon plans to ensure DEA and NJ DEP Compliance.

OOS / CAPA tracking as well as GMP documentation review may be required and will be assigned on an as needed basis. Review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review includes assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.   Qualifications: BS degree in Chemistry / Microbiology and minimum of 8 - 10 years of relevant experience in a pharmaceutical quality system environment. Or MS/PhD degree with minimum of 5 – 7 years of relevant experience in quality assurance / pharmaceutical quality system operations environment. Technical Skills Excellent working knowledge of pharmaceutical quality system requirements and international regulatory requirements. Strong written and oral communication skills. Must be highly organized with attention to detail and capable of multi-tasking and used to a fast-paced environment. Ability to work on complex issues where analysis of situations or data requires an in-depth evaluation of various factors. Experience working with sterile injectable drugs and ASQ Certifications (e.g., CQE, CQA) are desirable. Advanced knowledge of computer software to perform trending and prepare presentations to management (MS Word, MS Excel, MS PowerPoint, etc.)

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

to apply:

https://recruiting.paylocity.com/recruiting/jobs/All/0ed1b5d7-5087-454d-8802-0011c6ebad67/NEVAKAR-LLC