Sr. Manager QA and Compliance

Job Details: Job Location: 49 NAPOLEON CT

• SOMERSET, NJ, Position Type: Full Time, Education Level: 2 Year Degree, Salary Range: $1.00 - $1.00Salary, Travel Percentage: Up to 25%, Job Category: Pharmaceutical, Solaris Pharma Corporation is a leading specialty pharmaceutical company committed to the development and commercialization of high-quality, specialty pharmaceutical products. Solaris Pharma Corporation employs an experienced R&D and management team focused on right-first-time development while maintaining the highest quality standards. With a strong financial position and employee centric focus, the company strives to be a pacesetter in the specialty pharmaceutical market. Solaris Pharma Corporation is seeking a: Manager, Quality Assurance and Compliance/Sr. Manager Quality Assurance and Compliance (Depending on experience).

Responsibilities

Assist the Director of Quality Assurance in Implementing Quality Systems within the QC/cGMP Laboratory Create and implement Standard Operating Procedures (SOPs) related to Quality Systems and other technical areas with the assistance of SMEs Manage cGMP Quality Systems Review and approve Change Controls, CAPAs, and LIRs/Investigations for internal/external departments Provide oversite to Contract Drug Manufacturing Organizations (CDMOs) Review and approve analytical method validation protocols, reports, methods and specifications Support the Vendor Management Program Perform general data review Provide oversite of the cGMP laboratory from a compliance perspective Perform batch record review and provide oversite to personnel performing batch record review Act as Auditor/Co-Auditor during onsite audits of 3rd parties Perform internal audits.

Manage Day to Day workload Manage/provide oversite to QA personnel Provide oversite to QA personnel during the execution of Bioequivalence (BE) studies Assist with receipt of QC samples Act as representative for QA during onsite meetings with Sr. Leadership Manage review and tracking of external change controls, complaints, compendia updates and updates to specification/methods/protocols Generate COAs for the release of ANDA and Commercial batches Host Health Authority (HA) Inspections Assist Director of Quality Assurance and Technical Teams with the compilation of HA responses Perform administrative tasks as required by the position noted and as requested by the Director of Quality Assurance Perform minimum task as described by the job description and as assigned by the Director of Quality Assurance Qualifications: BS/BA degree in chemistry, biology, allied health, or chemical engineering Advanced degree preferred in Sciences, Regulatory Affairs and/or Quality Assurance but not required At least 10-15 years of experience in pharmaceutical industry and/or relative experience

• Knowledge of cGMPs and GLPs ASQ certifications are a plus in lieu of experience Experience performing analytical data review Previous Analytical laboratory/testing experience a plus Previous Management experience a plus Must be a collaborative self-starter Must be able to work independently and meet required timelines Must be able to work in a fast-paced environment Excellent communication/soft skills and the ability to negotiate Exhibits skills to think outside of the “box” Proactive and takes initiative in the absence of Direct Manager Must be able to travel up to 15% - 20% of the time upon request Must be able to lift up to 50 lbs.