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.
Skills Required
- BS/BA degree in chemistry, biology, allied health, or chemical engineering
- Advanced degree in Sciences, Regulatory Affairs or Quality Assurance
- 10-15 years of experience in the pharmaceutical industry or relevant experience
- Knowledge of cGMPs and GLPs
- ASQ certifications
- Experience performing analytical data review
- Previous analytical laboratory/testing experience
- Previous management experience
- Ability to travel up to 15-20% as requested
- Ability to lift up to 50 lbs.
- Strong communication, collaboration, independence, initiative, and ability to meet timelines in fast-paced environments
What We Do
Solaris Pharma Corporation is a leading specialty pharmaceutical company committed to the identifying, developing, and marketing of high-quality, complex generic and specialty pharmaceutical products. The company aims to be a pacesetter in the niche pharmaceutical market by developing a broad portfolio of such products, providing patients with high-quality, affordable, effective, and value-added options.
