The Director of Quality Assurance will report to the Sr. Director, Quality Assurance. This position will be responsible for quality and regulatory compliance of GMP and will assure the quality aspects of clinical and commercial drug substance/drug product manufacturing at contract service providers (CSP). This position will lead the Relypsa quality team with the development and management of Relypsa’s internal quality systems and will assure all systems, processes and their outcomes comply with applicable national and international standards (FDA, EMA), regulations and guidelines.
-Lead the Relypsa quality team in the development, establishment and maintenance of internal Quality Systems processes and procedures (e.g., change control, training, audit, CSP management, deviation and CAPA) that complies with applicable GMP standards, regulations and guidelines.
-Oversee and be ultimately responsible for Quality Assurance (QA) programs and activities; this includes overseeing and assisting with training and auditing programs, as well as the review of SOPs, investigations, specifications, methods, reports (analytical and process) and manufacturing records.
-Work directly with operating entities (internal and CSPs) to ensure that
Relypsa products (i.e., drug substance or drug product) meet all required
quality standards and specifications.
-Provide effective QA support for the manufacturing and disposition of Relypsa products. Responsible for release or rejection of GMP products and utilize QA staff to manage the timeline and assure on timely delivery of approved products.
-Provide leadership to the QA team and other functional departments to ensure that CSPs achieve and maintain the appropriate levels of GMP compliance and provide quality services to Relypsa. In addition, work with CSPs to ensure CSPs’ cGMP processes and procedures provide continuous evaluations and improvements to their quality systems.
-Responsible for preparation, review and approval of Quality Agreements with CSPs.
-Conduct CSP audits, provide QA guidance and support for supplier
qualification, technology transfer, scale-up, validation and other GMP activities associated with Relypsa products manufactured by CSPs.
-Facilitate resolution of quality issues with internal and external parties in a timely manner. Coordinate communications with CSPs and internal team for quality issues.
-Review and approve CMC sections of regulatory filings.
-Represent QA department at project team meetings.
-Provide leadership and management within the department through a
structural process of objective setting, performance appraisal and individual development as appropriate.
-BA or BS degree in a scientific discipline. At least 15 years of experience in Quality Assurance at an operational level supporting manufacturing, quality control in a pharmaceutical or biotech environment. Minimum of 5 years in outsourced manufacturing environment. An advanced degree in sciences would be a plus.
-Experience with Phase 3 and/or commercial drug product manufacturing
required. Recent experience in preparation of CMC sections of US or EU
regulatory approval (e.g., NDAs) is desirable.
-Prior experience related to managing quality systems in technology transfer, scale up and validation.
-In-depth knowledge and full understanding of pharmaceutical GMPs (US and
-Must understand standards of practice for the manufacture of solid dosage
-Experience with effectively managing FDA inspection, working with regulators and supplier audits
-Must have excellent verbal, written, interpersonal, organizational and
-Demonstrate ability to manage staff and projects (direct and indirectly) and variable workloads with demanding timelines.
-Position requires 10-20% travel.
As an employee of Relypsa, you will actively contribute to the development of potential new products. We provide opportunities for all employees to collaborate, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs and stock options reflect Relypsa’s high regard for our employees.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
To apply for this position, please send your resume to firstname.lastname@example.org.