Director/Senior Director Quality Assurance - San Ramon, CA | Biospace
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Director/Senior Director Quality Assurance

Galena Biopharma

Location:
San Ramon, CA
Posted Date:
11/14/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Job Summary:
As the leader of QA at Galena, this position is responsible for the overall quality functions for the corporation on a global basis.  The QA lead formulates, prioritizes, executes and drives the GxP quality strategy to include, but not limited to, communicating the company's quality programs/vision to internal and external stakeholders; development and optimization of processes and procedures that meet quality standards; training and development; participation of selection and oversight of quality contract service providers; Subject matter expert for all areas related to quality assurance.

Essential Duties And Primary Responsibilities:
•   Develops and executes short and long-term strategies and objectives for the quality function with an outlook to refine and realign of the systems as needed
•   Ensures the planning and hands-on implementation of quality programs including, but not limited to document and quality systems; quality assurance (QA); CAPAs; OOS/OOTs; change and document control; batch record review and approvals; product labeling and specifications; quality standards and policies; audits and investigations; analytical test records and reports; disposition of all finished products; retention and workforce planning; regulatory compliance; and metrics/measurements/results
•   Continually assesses the competitiveness of all quality programs and practices
•   Coordinates interactions with finance team to ensure quality programs have adequate budget and resources to support approved scope
•   Key stakeholder of the electronic document management systems (EDMS); ongoing oversight after validation and release
•   Proposes and advances quality technical tools to ensure goals and objectives are met in the most efficient and metrics-driven way as possible
•   Remains current on global regulations, industry trends, current practices, new developments, and applicable laws regarding quality
•   Provides effective QA support for the review disposition of clinical lots
•   Reviews and approves Production Mater and Executed Records, Specifications, Test Methods, Validation, Protocols and Stability Protocols
•   Performs QA Review of master batch records, executed batch records, test results and certificates of Analysis from CMOs, including any deviation and investigation reports related to lot release for drug substance or drug product as assigned
•   Responsible for the planning, scheduling, conduct and reporting of internal and external audits such facility approval audits and PAI (i.e., CMOs, CROs, analytical labs, etc.)
•   Works directly with operating entities (internal CMC & SC and CMOs) to ensure that clinical drug substance and drug product meet all required quality standards and specifications.
•   Participates in due diligence visits and/or performs audits for the qualification of new CMOs as assigned
•   Reports audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented and documented
•   Initiates or revises internal SOPs applicable to internal functions as well as outsourced functions
•   Provides internal GXP training as required    

Requirements

JOB SKILLS, ABILITIES AND QUALIFICATIONS

• Minimum of a Bachelor's of Science degree in life sciences or other relevant biologic discipline required; Master's degree preferred
•   10+ years of relevant, progressive and broad-based biologics development experience required, Preferably has hands on experience in Clinical GCP as well as GMP Quality Assurance
•   Experience designing, refining and executing quality system road maps and strategies required
•   Ability to travel up to 25%
•   Significant experience and understanding of GxP (i.e., GMP, GCP, GLP) environments and regulations required
•   Analyze reports, metrics and results as required; provide SME and strategic guidance based on findings
•   Demonstrate ability to build relationships and work collaboratively with a variety of individuals within the department, company and external vendors, and customers alike
•   Demonstrate ability to work in fast-paced, team-oriented and self-directed entrepreneurial environment
•   Demonstrate strategic planning with proven ability to communicate a vision and drive results
•   Ensure that policies and procedures are followed in accordance with federal, state, international and company/department regulations and requirements
•   Excellent verbal and written communication skills, an innovative approach to problem-solving, an integrated view of business/scientific issues, and a strong work ethic
•   Significant experience using computers and software programs required (e.g., MS Office Suite; EDMS software)