Director of Quality and Regulatory - San Francisco , CA | Biospace
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Director of Quality and Regulatory

Medicines360

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Location:
San Francisco , CA
Posted Date:
5/30/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

MEDICINES360 MISSION:
To expand access to quality medicines for women in the U.S. and globally regardless of their socioeconomic status, insurance coverage, or geographic location

ABOUT MEDICINES360:
We are an innovative nonprofit global pharmaceutical company focused exclusively on women’s health. Formed in 2009, we develop products and bring them to market in order to provide all women with the ability to obtain and choose quality medicines.  We have established a groundbreaking approach to expand access.  It starts with our nonprofit mission and singular focus on creating healthcare access to for all women. We research the health needs of women and identify gaps and barriers; develop women’s health products and create innovative approaches to fill those gaps and remove those barriers; and we also form partnerships to bring these products to market in a way that broadens healthcare access for women and reinvest proceeds into advocacy, education, and additional product and partnership development to further our mission in the U.S. and globally. Medicines360 is proud to be a leader in expanding access to quality medicines for women. We believe that by supporting the products and partnerships we develop, everyone can play a role in helping women access medicines that can help improve their lives.

POSITION SUMMARY:
This position supports the quality and CMC regulatory activities of Medicines360 and its affiliates. They will serve as the primary back-up to the VP of Quality in the performance of quality functions, and will support the regulatory department with CMC expertise for FDA and developing countries filings.

Requirements

ESSENTIAL DUTIES AND RESPONSIBILITIES:
•Review of batch record and release documentation for disposition of IND or commercial product(s)
•Manage pharmacovigilance and product complaint systems and triage critical case reports
•Lead the development, review, and compilation of CMC documentation for regulatory submissions  
•Provide strategic and tactical regulatory CMC guidance on regulatory submissions and manufacturing development
•Ensure data integrity throughout documentation and/or submissions
•Monitor Quality Systems processes (training, deviations, CAPAs, etc.) processes and implementation
•Engage with the contracted manufacturing organization(s) to manage change controls and evaluate for regulatory implications
•Conduct internal and external audits with VP Quality
•Represent quality and regulatory departments during regulatory inspections
•Collaborate with cross-functional teams in the preparation of strategy for meetings with regulatory authorities
•Quality and Regulatory oversight of the contract manufacturing organization(s) to ensure a coherent global regulatory strategy
•Development of strategies for and implementation of efficient and effective regulatory processes


ESSENTIAL QUALIFICATIONS:
•Bachelor’s degree, with advanced degrees and/or certifications a plus (e.g. RAC)
•10-15 years’ experience in the FDA-regulatory industry
•At least 5 years managing people and/or projects
•Pragmatic and goal-oriented
•Prior experience in a relevant lab or manufacturing environment is preferred
•Prior experience in quality or regulatory functions, with regard to developing countries, is preferred
•Experience with devices and/or combination
products in an FDA-regulated industry
•Strong background in CMC regulatory activities
•Strong understanding of GxP (especially GMP)
•Previous experience with an open NDA and/or IND
•Previous engagement with and contribution to a well-developed quality management system
*Experience leading audits, either internally or externally, preferable with either GMP or GCP
•Strong technical writing skills (e.g. SOPs, policies, regulatory communications, deviations)
•Strong communication skills, including trainings and/or presentations
•Previous experience participating in regulatory inspections
•Experience with an EDMS (e.g. Veeva)
•Proficiency with Microsoft Office and Adobe Acrobat
•Ability to work well in teams and independently, both within the company and with external partners
•Ability to travel, both internationally and domestically