Position Title: Director of Quality

Reports To: SVP, QA & Product Safety

FLSA Status: Full-time, Exempt

Location: Flex-SF/Remote

In Office Presence:  20% monthly

Curae Pharma360 MISSION: A mission-driven pharmaceutical company committed to advancing equitable, reliable access to affordable medicines for everyone.

ABOUT Curae Pharma360:

We are an innovative pharmaceutical company working to build a future where everyone receives the medicines they need. Formed in 2012, we develop products and bring them to market to provide equitable, reliable access to affordable medicines for everyone. Curae Pharma360 is a majority owned subsidiary of Medicines360, a mission-driven nonprofit pharmaceutical organization focused on women’s health. Building on the over 10-year track record of Medicines360, Curae is a business extension to improve access to care in the USA.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Working within the environment of a virtual company with operations performed by its vendors/CMOs/3PLs, participate in development and implementation of Quality and/or GxP activities supporting commercial distribution of the company’s over the counter (OTC) and prescription (Rx) generic products
• Implementation of DSCSA (product serialization) for Rx generic products; coordination with serialization vendors, CMOs, and 3PLs, and implementation of required internal systems to ensure compliance
• Responsible for timely product release for commercial distribution by review of specified quality documentation and evaluation of any transport temperature excursions
• Post-approval (marketed) product surveillance (for generic Rx and OTC products), including pharmacovigilance and product quality complaints consistent with established PV and quality agreements and regulatory requirements
• Ensure Quality Oversight of vendors/CMOs/3PLs by performing GxP compliance audits per compliance and business needs and established agreements; prepare and carry out annual audit plan
• Carry out internal reviews, audits, and/or self-inspections to ensure operations are compliant to Curae’s quality standards
• Maintenance of up-to-date Quality and/or PV Agreements with vendors/CMOs/3PLs
• Review labeling and printed packaging components to ensure accuracy, consistency with regulatory filings, and compliance with regulations
• Ensure Curae GXP Policies, SOPs (Standard Operating Procedures), and GxP controlled documents are drafted, reviewed, approved, and implemented within an existing electronic document management system (Veeva EDMS)

ESSENTIAL SKILLS & QUALIFICATIONS:

• Minimum of 12 years of quality experience with at least 8 years in a supervisory role.
• Degree in a relevant scientific discipline
• A successful track record with implementation and management of quality functions for Rx generics and OTC products in commercial stages (post-market), e.g., oversight of PV and/or customer call centers
• Strong background or direct experience (preferred) with implementation of DSCSA and serialization
• Currently valid CA Board of Pharmacy License as a Designated Representative or willingness to obtain license
• Experience with Rx generics and OTC products is a plus
• Broad knowledge of FDA Regulatory, CMC, and GxP requirements (e.g., cGMP / GDP / GCP / GVP) and other applicable technical or compliance standards (e.g., USP, ISO)
• Experience with conducting GxP compliance audits a plus.
• Personal commitment to Curae’s mission.
• High standards of personal and professional integrity and positive attitude and ability to collaborate, work through obstacles, and participate effectively in cross-functional teams.
• Experience with constructive engagement and oversight of vendors/CMOs/3PLs
• Availability for travel, both domestic and international
• Ability to recommend and apply effective tactical policies, processes, and procedures to meet business objectives
• Proactive, technically proficient, resourceful, well organized, constructive, and pragmatic
• Capable of prioritizing and handling multiple projects simultaneously
• Excellent communication skills (both spoken and written) and ability to effectively work with others; good interpersonal skills a must.

PHYSICAL DEMANDS / MISC:

• Ability to sit at a workstation for an extended period (in-office or remote)
• While performing the duties of this job, the employee may need to stand, sit, stoop, walk, talk, hear, reach, and use hands and fingers to operate a computer keyboard

Effective October 1, 2021, Medicines360 requires all staff, contractors, and consultants to be fully vaccinated against COVID-19. Proof of vaccination or a valid medical or religious exemption is required prior to the commencement of employment.

CuraePharma360 is committed to a diverse workplace and is committed to equal opportunity employment for all job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. CuraePharma360 complies with all applicable local, state and national laws governing nondiscrimination in employment.