POSITION: Director, Quality Assurance
LOCATION: Fremont, CA – conveniently located near Dumbarton Bridge (hwy 84)
Quark Pharmaceuticals, Inc. is a late clinical-stage pharmaceutical company, a leader in the discovery and development of novel RNAi-based therapeutics for unmet medical needs. Two products, which were granted Orphan designation, QPI -1002 and QP -1007 are in global phase III pivotal clinical studies for Delayed Graft Function (DGF) and Non Arteritic Ischemic Optic Neuropathy (NAION) respectively
Quark is vertically integrated from gene discovery to novel therapeutics. Assuring its broad pipeline of clinical and preclinical product candidates is the internally developed technology, which includes Quark’s RNAi platform technology and its delivery to a host of organs. Quark products and technology have freedom to operate in the nucleic acid intellectual property space.
The company has a string of enabling alliances on products and technologies. QPI -1002 is exclusively option licensed to Novartis worldwide; PF-655 is licensed to Pfizer worldwide on an exclusive basis. QPI -1007 is licensed to RiboQuark, Quark’s Chinese joint venture company with Suzhou Ribo Life Science Co., Ltd (Ribo) for China and certain additional countries and to Biocon Limited for India and additional countries. (Read more about the company’s collaborations at www.quarkpharma.com}
Quark is a privately held company incorporated in California. The headquarter of Quark is located at 6501 Dumbarton Circle, Fremont, CA 94555, USA, and the R&D facilities at 2990 Wilderness Place, in Boulder Colorado 80301 and at QBI Enterprises, Ltd. in Nes Ziona, Israel. QBI Enterprises, Ltd. is a wholly owned subsidiary of Quark Pharmaceuticals, Inc.
The Director, Quality Assurance oversees the development, implementation and maintenance of quality assurance systems and activities under the leadership of the Vice President of Regulatory Affairs and Quality Assurance. S/he is responsible for companywide compliance with GXPs. In this role s/he oversees generation and review of documents used in good manufacturing practices, good clinical practices, good laboratory practices, and good vigilance practices. Duties include coordination of interdepartmental activities, leading investigations and resolving potential product quality issues to improve efficiency, and assuring compliance in conduct of clinical and nonclinical studies.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Ensure the compliance of contract manufacturing and testing activities with respect to company procedures as well as FDA, EU, ICH, and other regulatory expectations and requirements.
- Ensure the compliance of contract research organizations in the conduct of clinical and nonclinical trials.
- Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to GLP quality systems and management.
- Provide oversight of contracted GLP QA activities
- Host and manage all GxP regulatory inspections (FDA, EU, Global, and Notified Body including Partner QP audits).
- Cross collaboration proficiency with other functions such as Clinical, Manufacturing, Regulatory and Finance.
- Perform batch record review and lot disposition activities for intermediates, drug substance and drug product, including review of analytical data, testing records, and stability data.
- Develop quality plans and conduct/facilitate audits of service providers including GLP laboratories and CROs conducting clinical and nonclinical trials on behalf of Quark.
- Establish and maintain Quality Systems and procedures (auditing, change control, corrective and preventive actions, deviations, investigations, vendor qualification, etc.) and pursue continuous improvements throughout the organization.
- Manage all internal and external customer queries with respect to regulatory compliance and quality matters.
- Maintain employee training program.
- Excellent problem solving and communication skills.
- Provide supervision, guidance and mentoring to direct reports.
- Ability to interface with all levels of management.
- Promote quality culture throughout the organization
- Identify and implement continuous improvement initiatives that seek to eliminate inefficiency, reduce cost and improve product quality.
- Bachelor’s Degree in physical/life sciences
- Eight or more years of Quality Assurance experience in the pharmaceutical or biotech industries required.
- Knowledgeable in ICH/cGMP/GLP/GCP, and regulatory guidelines as applied to the entire development lifecycle of biotech and pharmaceutical products.
- Flexibility and willingness to multitask and change priorities in a dynamic environment.
- Strong organizational, planning, problem solving, and decision-making skills.
- Excellent written and verbal communication skills and collaborative working style.
- Ability to work independently and keep management updated.
To apply, please send CV to firstname.lastname@example.org