Director of Quality Assurance

About Medicines360

At Medicines360, we are more than a health innovation organization—we are a catalyst for change. We are fearless in our pursuit of creative approaches to solving consequential women’s health issues and transforming novel ideas into life-changing products that improve the lives of all women, and especially the undeserved. We are fiercely dedicated to our mission of improving women’s health worldwide. Our launched products address pressing health concerns of women, providing them with the products they need to live healthier, more fulfilled lives.  For more information on Medicines360 please visit Medicines360.org

Position Title: Director of Quality Assurance

Reports To: Chief Executive Officer

FLSA Status: Full-time, Exempt   

Location: San Francisco – Hybrid

In-office Presences: Tuesday, Wednesday and Thursday

POSITION SUMMARY:

This position establishes and implements the quality and GXP strategies of Medicines360 and its affiliates. The Director of Quality Assurance will collaborate closely with other internal functional areas and externally with partners and contract facilities to develop appropriate strategies and objectives that drive continuous improvement in quality and support regulatory compliance and product safety. S/he is responsible for the implementation of these strategies in order to achieve, maintain, and improve effective programs and performance, companywide. Medicines360 is a commercial stage company with an approved complex drug-device combination product and a development pipeline of drug and device products.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

· Develops, implements, prioritizes, and communicates the company’s quality strategy and its quality programs, and, on a broader basis, promotes effective quality management principles throughout the organization.

· Represents Quality issues at Executive Management and partnership meetings and develops metrics to evaluate and ensure the effectiveness of such programs, providing periodic status reports to executive management.

· Translates the company’s quality strategy into tactical and pragmatic policies, processes, and procedures to effectively meet global regulatory, medical/health, and legislative standards and ensure the overall quality of Medicines360 products.

· Monitors and assesses the impact of new regulatory requirements on QA and business.

· Mentors QA personnel for career development and advancement.

GXP Compliance

·   Ensures M360 Quality Systems and processes effectively meet current and evolving global regulatory, medical/health, and legislative standards, including compliance with GXP, QSMR, ICH, and/or compendial standards as relevant. 

·  Ensures M360 GXP policies, procedures, and controlled documents are managed within an electronic document management system (Veeva EDMS). Manage and maintain GXP related Policies, SOPs (Standard Operating Procedures), and supporting GXP documents; ensures the EDMS is available for the administration of SOPs for other departments. Performs final review and approval of all relevant policies and SOPs.

·  Develops and manages GXP training programs of M360 personnel in collaboration with the other functional heads.

·  Serves as primary QA contact for FDA inspections or other Health Authority inspections. Responsible for inspection readiness at all times, manages the inspection, and provides adequate and timely response to observations.

·  Prepares annual audit plan and carries out internal reviews and/or self-inspections to ensure operations are compliant to Medicines360’s quality standards and follow-up on CAPA implementation.

·  Ensures third party Quality Oversight by performing audits of third-party manufacturers, packagers, distributors, testing laboratories as per compliance and business needs and established agreements.

·  Reviews change control documentation associated with M360 products.

·  Acts as a primary point of contact for commercial partners and CMOs on quality and CMC matters

·  Supports Clinical operations and studies, including:

·  Audit of CRO(s), and GCP compliance oversight of CRO(s) and clinical study sites by coordination with Clinical

·  Review and/or approval of Clinical Study Protocols and investigator's brochure

·  Review and approval of clinical SOPs and policies

Liletta Manufacturing and Supply

· Maintain and manage Medicines360's Quality operations necessary to support manufacturing and supply of a commercial combination product (Liletta®) in the United States, to include:

·  Product Release: Responsible for timely product releases for commercial distribution; participate in supply chain planning and activities

·  Post-approval product surveillance, including pharmacovigilance, complaints, and Field Alerts (detail below)

·  Review and disposition of critical manufacturing deviations and/or transport temperature excursions

·  Development, review, and processing of CMC change controls

·  Review of CMC related regulatory submissions and supporting documentation, including support of IND and NDA annual reports

·  Audit and GXP compliance oversight of the Liletta CMO, including validation maintenance for manufacturing process and analytical methods

·  Maintenance of up-to-date Quality Agreements

·  Support of SHI device manufacturing and suppliers, including:

·  Maintenance of Design History File and inserter device compliance

·  Review of significant manufacturing deviations and critical change controls for SHI

·  Audit and compliance oversight of device suppliers (jointly with partners)

Avibela Manufacturing and Supply

·  Assists with development and review of CMC-related regulatory submissions in Avibela territories.

·  Negotiates and implements Quality and Pharmacovigilance agreements with Avibela distribution partners, and integration with existing policies and SOPs.

·  Participates in Avibela supply chain planning and activities for commercial distribution.

·  Reviews labeling and printed packaging components for compliance with regulations and approved labeling content.

·  Performs technical review and processing of CMC change controls.

·  Assists with technical transfer activities to qualify an alternate contract manufacturing site.

·  Engage with the contracted manufacturing organization to manage change controls and evaluate for regulatory implications

Veeva

· Oversight of electronic Document/Record Management system (EDMS): direct and oversee maintenance, enhancement planning, document management operations, release management, etc.

·  Monitor Quality Systems processes (training, deviations, CAPAs, etc.) processes and implementation

·  Corporate Policies: Coordinate with internal partners and senior leaders to develop, influence and ensure compliance with corporate and industry standards, policies.

Product Safety (Pharmacovigilance and Product Complaints)

·  Assist with implementation of an effective Pharmacovigilance (PV) system consistent with established PV agreements and regulatory requirements, to ensure timely submission of PADERs, supporting ICSRs, and/or other PV submissions.

·  Assist with implementation of an effective Product Quality Complaint process, consistent with Quality Agreement(s) and regulatory requirements.

·  Serves as primary contact with FDA for product recalls and Field Alerts, and coordinates with Regulatory on CMC-related Information Requests.

·  Ensures periodic internal training on PV and product complaints to ensure compliance with SOPs, Policies, and regulatory requirements.

New Product and/or Manufacturing Development

·  Participates in new product or manufacturing due diligence and subsequent development to provide input on technical (manufacturing and analytical), quality (GMP compliance), and CMC matters

·  Provides oversight of GLP matters, as needed

ESSENTIAL SKILLS & QUALIFICATIONS:

·  Minimum of 15 years of quality experience with at least 8 years in a manager/leadership role.

·  Advanced degree in a relevant scientific discipline

·  High level of enthusiasm, personal sense of urgency, and capacity to overcome obstacles

·  Preferred - have the ability to become a Designated Representative for a Wholesaler through the CA State Board of Pharmacy

·  Effective and proactive strategic thinking capabilities

·  Ability to identify problems and creatively solve them

·  A successful track record building, directing and providing strategic leadership for quality

functions in the pharmaceutical industry in development and commercial stages.

·  Experience with combination drug-device products is a plus.

·  Broad knowledge of FDA Regulatory requirements (cGMP / GLP / GCP / GVP) and other

applicable (e.g., international) standards of compliance

·  Personal commitment to Medicines360's mission.

·  Exceptional leadership capabilities. Exemplary personal and professional integrity and positive attitude and ability to collaborate, work through obstacles and influence cross functionally.

·  Ability to deal pragmatically with changes and shifts in priorities.

·  Experienced in engaging vendors/CMOs, including relationship management responsibilities.

·  Availability for travel, both domestic and international

·  Excellent manager of direct reports.

·  Ability to successfully translate company’s quality and/or regulatory strategies and initiatives into effective and pragmatic tactical policies, processes, and procedures to meet business objectives

·  Innovative, technical, resourceful, and well organized

·  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:

 ·  Must be able to remain in a stationary position 50% of the time.

·  The person in this position may need to occasionally move throughout the office to attend meetings in different rooms. 

·  Continuously operates a computer and occasionally uses other office productivity machinery, such as copy machines, and computer printer.

·  The ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in these situations.

·  The ability to observe details at close range (within a few feet of the observer).

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Medicines360 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. Medicines360 complies with all applicable local, state, and national laws governing nondiscrimination in employment.

Salary : $225