Director Quality Assurance & Compliance - Relocation may be provided - Job # 2295

Additional Information
  • For confidential consideration please submit a resume and salary history to claire@fullscalesolutions.com.
  • Please be sure to include the job number with your submission.
  • Full Scale Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
Client Synopsis:

Full Scale Solutions is currently recruiting for the following DALLAS / FORT WORTH BASED position.

Essential Duties and Responsibilities:

Responsible for overseeing and coordinating the quality assurance (QA) and quality compliance (QComp) programs. Develops, interprets, and implements quality policies, manages quality systems, and facilitates regulatory compliance inspections. Manages the internal and external audit program, Supplier Quality Management, regulatory intelligence and readiness, and is the quality assurance reviewer/approver. Ensures compliance with applicable regulations for the company’s products including products at different clinical stages. Support the GMP manufacturing, testing and release of finished product under FDA standards and internal procedures and monitors the compliance level of manufacturing activities by evaluating and reporting quality data. Also responsible for conducting investigations into GMP-related issues, management of the QA change control process, SOP preparation/revisions, and GMP training programs.

Duties include, but are not limited to:

  • Oversee the internal and external audit program, which includes, focus on cGMP compliance, regulatory agency inspection readiness, and for-cause inspections.
  • Recommend systems for audit; write audit plans, coordinate scheduling, conduct and write reports to close audits. Follow-up on corrective actions.
  • Ensure proper coordination of customer-initiated audits and mock regulatory inspections, and manage regulatory facility inspections.
  • Manage documentation, reporting, and closure of compliance issues.
  • Conduct trend analysis of audit results and provide Executive management with initial root cause analysis.
  • Review GMP quality metrics. Analyze data relating to process validations, process controls, and continuous process improvement efforts. Coordinate the necessary quality adjustments.
  • Review relevant GMP documents for compliance to company SOPs, quality systems, and regulatory requirements.
  • Oversee the following investigations: nonconforming product, customer complaint, laboratory out-of-specification, and corrective and preventive action. Ensure all investigations are performed and closed in a timely fashion. Monitor and report adverse events.
  • Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and policies. Participate in or lead teams for special projects as assigned.
  • Develop and work with staff to implement quality process controls relating to all areas of operation, including the following systems: quality, facilities and equipment, materials management, production, packaging, and labeling.
  • Prepare and conduct the Quality Management Review meetings with senior management.
  • Advises executive management on external environment and strategic compliance trends impacting our business.
  • Manage company-wide training initiatives and document control systems.
  • Responsible for performing secondary activities relating to the handling, processing and analysis of narcotics and other controlled substances, in areas where narcotics and other controlled substances may be present.

Requirements:

  • Bachelor's of Science degree in a related scientific discipline.
  • Minimum 10 years of Quality Assurance experience in pharmaceutical or related industry, 5 years of which includes management experience; or equivalent combination of education, training and experience.
  • Extensive working knowledge of GMP regulations and experience with regulatory compliance inspections; Strong knowledge and experience with 21CFR210, and 21CFR211.
  • Ability to effectively lead teams and manage staff.
  • Strong project management and organizational skills.
  • Responsible for performing secondary activities relating to the handling, processing and analysis of narcotics and other controlled substances, in areas where narcotics and other controlled substances may be present.

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