Sr. Manager QA and Compliance

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

• 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.