Current Open Positions
Position: QualityAssurance Specialist
Location: Boulder Colorado
The QA Specialist is responsible for a variety of activities ensuring compliance with applicable regulatory requirements and ensuring company compliance with ICH and GXP standards.
- Review and maintain master and executed batch records, in-process/finished product quality control data for timely disposition of drug substance and drug product intended for human clinical use.
- Maintain quality systems and procedures compliant with applicable regulatory standards such as change control, deviation, MRB and CAPA systems
- Review Quality System SOP’s
- Issue and maintain analytical methods, product specifications and Certificates of Analysis.
- Track and maintain stability protocols and associated stability data for drug substance and drug product, including stability tables for regulatory submissions.
- Support Supply Chain including assessment of temperature excursions and acceptability of drug product.
- Manage Vendor Qualification program, including activities associated with vendors and contracted service providers’ approvals, agreements and audit reports.
- Review/edit regulatory documents as requested.
- Ad hoc responsibilities as assigned.
- Have a working knowledge of quality assurance systems, methods and procedures.
- Good working knowledge of Quality Systems and GXP standards applicable to clinical products.
- Team player who is detail and quality-oriented with solid understanding of quality assurance principles, systems, methods and procedures.
- Excellent attitude with good verbal, interpersonal communication, excellent judgment and multitasking skills who can adapt to changing priorities.
- Working knowledge in biopharmaceuticals and oligonucleotides desirable.
- Possesses critical thinking and excellent technical writing skills.
- Ability to work independently in a high-paced environment with tight timelines, while maintaining accuracy and quality.
- Proficient with computers and word processing software (i.e. Microsoft Office products).
- Bachelors of Science degree in a scientific discipline or equivalent.
- Minimum 3 years of relevant experience in GMP/GCP environment applying QA concepts.
Position: Quality Assurance Manager
Location: Boulder Colorado
The primary responsibility of the QA Manager will be to assure the compliance and quality of drug substance and drug product manufacturing and testing activities with respect to procedures and applicable domestic and international regulatory expectations and requirements.
- Ensure the compliance of manufacturing and testing activities with respect to company procedures as well as FDA, EU, ICH, and other regulatory expectations and requirements.
- Perform batch record review and lot disposition activities for intermediates, drug substance and drug product.
- Perform review of analytical data and testing records for intermediates, drug substance and drug product.
- Perform review of stability data and testing records for drug substance and drug product.
- Provide quality input for failure analysis, problem solving, and risk assessment and mitigation activities related to the manufacture or testing of intermediates, drug substance and drug product.
- Resolve moderately complex deviations, including Out-of-Specification / Out-of-Trend investigations, or any other quality events.
- Execute current Quality Systems procedures (auditing, change control, corrective and preventive actions, deviations, investigations, vendor qualification, etc).
- Maintain employee training program.
- Provide support to development groups regarding process and analytical method transfer activities.
- Provide quality oversight of contract manufacturing organizations.
- Perform external audits of suppliers, contract manufacturing organizations, and contract testing laboratories, clinical research organizations as necessary.
- Ability to perform GCP document audits to ensure regulatory compliance.
- Provide GCP compliance interpretation and other supportive services necessary to maintain regulatory compliance.
- Excellent problem solving and communication skills.
- Ability to interface with all levels of management.
- Ability to manage multiple priorities with aggressive timelines at a high level of productivity in a fast-paced environment.
- Promote quality culture throughout the organization.
- Ensure progress and completion of responsibilities in accordance with established departmental goals and project plans.
- Identify and implement continuous improvement initiatives that seek to eliminate inefficiency, reduce cost and improve product quality.
- Bachelors of science degree in a scientific discipline or equivalent.
work experience requirements
- 7 years experience in pharmaceutical or biotechnology industry with 5 years of direct responsibility in Quality Assurance.
- Phase 3/NDA experience preferred.
- Knowledge of FDA, EU, and ICH regulatory requirements and guidelines related to GMP and GCP operations.
- API and drug product formulation, aseptic filling, and finishing experience.
Position: Assistant Director/Director Pharmacovigilance
Location: Fremont, CA
The Assistant Director, Pharmacovigilance (PV) is responsible for ensuring compliance with SOPs and FDA and other health authorities for the reporting of adverse events to regulatory agencies, including 21CFR11 compliance for any applicable Quark Pharmaceuticals utilized electronic safety database, and for assisting the Vice President Pharmacovigilance with implementation of PV policy and procedures, medical review and validation of adverse experience reports.
- Assists VP Pharmacovigilance in assuring global reporting requirements are identified and met.
- Responsible for coordination with regulatory department the integration of global reporting requirements into pharmacovigilance work processes.
- Coordinates with VP Pharmacovigilance integration of safety database management and output to health authorities globally.
- Responsible for coordination of periodic internal audit of pharmacovigilance records to assure compliance with regulations.
- Develops guidelines and ensures the uniform and timely processing of adverse event reports.
- Acts as liaison internally and externally to project teams.
- May contact reporters and collects information directly from healthcare providers relevant to completing reporting requirements if required.
- Assists in the preparation of relevant sections of investigator brochures, protocols, Data Safety Update Reports, Individual Case Safety Reports, investigator communications, product development plan, pharmacovigilance plan and other reports as necessary.
- Assists in or provides support for coding of clinical adverse events for clinical and safety databases
- Provides medical evaluation and coding of adverse event reports.
- May assist in training of other Quark Pharmaceuticals employees in their role in identification /recognition and reporting of adverse events for clinical and safety related processes.
- MD or PharmD degree and a minimum of 7 years of clinical, safety or epidemiology experience, with a minimum of 5 years in industry.
- MD license required.
- Must have excellent working knowledge of clinical research and the drug development process. Must have knowledge and experience with drug safety (global preferred). Knowledge of drug development or clinical trials optimal.
- Experience with electronic drug safety databases and E2B submissions required.
Position: Drug Safety Associate
Location: Fremont, CA
The primary responsibility of the Drug Safety Associate (DSA) is to provide support to the Pharmacovigilance Department.
- The DSA will receive initial intake of clinical trial safety correspondence and be responsible for initial data entry into appropriate drug safety database and/or safety files.
- The DSA will establish and maintain filing systems on department-related business to achieve quick retrieval according to company standards, and liaise with other members of the clinical trial project team such as clinical trial associates, to ensure maintenance of the pharmacovigilance system and any needed supporting documentation for the clinical trial master file therefrom.
- The DSA will type correspondence to support the PV Department, compile data for Power Point and statistical reports, maintain calendars and coordinate meetings for the PV group.
- The DSA will assist with meeting and support activity involving vendors and CROs.
- The DSA will handle PV support and administrative projects as assigned.
- Bachelors Degree in Life Sciences or related field or equivalent relevant experience.
- Medical terminology coursework or MedDRA experience preferred.
- Intermediate to advanced computer skills. Must be proficient in Microsoft Outlook, Word, PowerPoint and Excel.
- Excellent written and oral communication skills, the ability to work independently, be flexible and have strong organizational skills.
- Good interpersonal skills
- Ability to handle multiple priorities.
- Good problem solving skills and the ability to make suggestions to improve efficiencies.
- Experience with Safety databases preferred.
- Experience with ArisG preferred.
How to Apply
To apply for a current open position please send your resume or curriculum vitae to Quark Pharmaceuticals as follows:
For US positions:
Quark Pharmaceuticals, Inc .
Attn: Human Resources
For Israel positions:
QBI Enterprises, Ltd.
Attn: Human Resources
Weizmann Science Park, P.O.B. 4071
Ness Ziona, 70400, Israel
Notice to Recruitment Agencies/Search Firms:
Please be aware that external placement fees are only available to Search Firms that have an executed Search Agreement with Quark Pharmaceuticals and that a specific search must be expressly authorized by Quark Pharmaceuticals. All unsolicited resumes/CV’s submitted through our Web site or to personal e-mail accounts of employees of Quark Pharmaceuticals shall be deemed property of Quark Pharmaceuticals. Quark Pharmaceuticals explicitly reserves the right to pursue and hire those candidates without any financial obligation to the recruiter or search firm. If you wish to develop a business relationship with Quark, you may do so only by providing your name, email address, phone number, agency name, and area(s) of specialty to the hyperlink to the appropriate HR group listed above. Quark does not accept phone solicitations . Quark will contact your company if there is a business need for your services.
To apply for a current open position please send your resume or curriculum vitae to Quark Pharmaceuticals as follows: Quark Pharmaceuticals, Inc . Attn: Human Resources Email: QBI Enterprises, Ltd. Attn: Human Resources Weizmann Science Park, P.O.B. 4071 Ness Ziona, 70400, Israel Email: Please be aware that external placement fees are only available to Search Firms that have an executed Search Agreement with Quark Pharmaceuticals and that a specific search must be expressly authorized by Quark Pharmaceuticals. All unsolicited resumes/CV’s submitted through our Web site or to personal e-mail accounts of employees of Quark Pharmaceuticals shall be deemed property of Quark Pharmaceuticals. Quark Pharmaceuticals explicitly reserves the right to pursue and hire those candidates without any financial obligation to the recruiter or search firm. If you wish to develop a business relationship with Quark, you may do so only by providing your name, email address, phone number, agency name, and area(s) of specialty to the hyperlink to the appropriate HR group listed above. . Quark will contact your company if there is a business need for your services.