Director, QA / Regulatory Compliance
South San Francisco, CA
Areas of Expertise Desired:
Achaogen, a biopharmaceutical company in early stage clinical development, is seeking an experienced and highly motivated individual for the position of Director QA / Regulatory Compliance, reporting directly to the Head of Regulatory Affairs and Quality. This position will be responsible for developing and implementing quality systems to ensure full compliance with applicable GCP, GLP and GMP requirements, other global regulatory requirements and quality standards.
The Director QA / Regulatory Compliance will provide day-to-day management of the QA function including oversight of QA and compliance initiatives, work with functional groups to provide direction and appropriate solutions for compliant operational practices, drive decision making and issue resolution on QA and compliance matters, and advise Management on areas of regulatory / business risks related to compliance activities.
• Establishes and oversees the internal quality systems and policies throughout the company including all activities related to GCP, GLP and GMP, SOPs and training, and supervises contractors and vendors engaged to support quality systems related activities.
• Ensures ongoing compliance with internal policies and SOPs, as well as applicable US and international regulatory requirements and quality standards with focus on investigational medicinal products.
• Leads and co-ordinates activities related to the qualification and auditing of vendors and subcontractors, including contract manufacturing organizations, contract research laboratories, and clinical contract research organizations.
• Develops internal and external audit plans and oversees the execution of these plans working with contract auditors. Assesses the results of audits and makes recommendations based on audit findings.
• Leads the co-ordination and preparation of activities related to regulatory agency inspections at company facilities, investigator sites and CRO's conducting client sponsored clinical and nonclinical investigations.
• Develops and coordinates the execution of a quality training plan including GXP and SOP training.
• Has accountability for the company’s document control system and related processes.
• At least 10 years’ experience in the Pharmaceutical or Biotechnology industry with a minimum of 6 years in a QA or regulatory compliance role.
• Current and strong working knowledge of GCP, GLP and GMP, CFR Title 21 and regulatory guidances including ICH quality, nonclinical, clinical and multidisciplinary guidance documents.
• Strong auditing experience; international experience preferred.
• Creative and pragmatic approach to problem solving and issue resolution.
• Well-developed critical reasoning skills combined with diplomatic interpersonal skills.
• Ability to communicate clearly and professionally both in writing and verbally
• Requires a Bachelors or Masters degree in a scientific discipline or equivalent combination of education and experience.
• A professional certification in quality, compliance or regulatory affairs preferred.
Preferred Additional Skills (i.e., Computer):
• Proficiency with MS Office, MS Project, quality system databases, electronic document management.
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