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Sr. Director, Quality Assurance

Chicago, IL

Posted: 11/20/2019 Employment Type: Direct Hire Job Category: Clinical: Quality Job Number: 2429

Job Description


The Senior Director of Quality Assurance leads the Quality Management System (QMS), Validation and Training functions within the Quality Assurance organization. The incumbent will partner with and serve as a back-up to their counterpart in San Diego in leading the engineering, GMP, GLP and Auditing functions within Quality Assurance. This position reports to the Vice President of Quality Assurance and Regulatory.

Responsibilities:
  • May serve as the QA release authority for the Company' s commercial products.
  • Oversee all internal SOPs and ensure that they are implemented and maintained as needed for compliance with all federal and state regulatory requirements.
  • Provide support to QA Training Manager in the management of employee quality training programs including the annual GMP and GCP training programs.
  • Serve as a QA resource to contractors and vendors as needed during investigations into product quality events.
  • Oversee field alert reporting and recall requirements for the Company, and coordinate directly with regulatory bodies, contractors and vendors as needed to ensure compliant handling of products under investigation.
  • Assist in the selection process of new contract manufacturers and packagers through site visits and site quality history evaluation.
  • Ensure that all materials purchased and all products produced at company facilities and by third parties on behalf of Client company meet corporate and regulatory compliance requirements.
  • Evaluate and implement continuous improvement processes that improve global quality systems and operational efficiency.
  • Maintain and encourage company-wide comprehensive knowledge of current and emerging GXP requirements and quality trends as they relate to Client’ s products.
  • Identify quality improvement opportunities within operations and partner with peers in Manufacturing to develop and implement solutions. Evaluate, propose and implement new processes and technologies as alternatives to optimize efficiencies in the
  • Manage the professional development of direct reports through deployment of a proactive talent management strategy, active coaching and mentoring.

Requirements / Qualifications:
  • Bachelor' s degree with a minimum of 15 years of progressive experience in US FDA-regulated pharmaceutical development and manufacturing of combination products.
  • Certification in Quality Management Systems for FDA preferred.
  • Minimum of 5 years of management responsibility of Quality Assurance teams.
  • Previous experience working in a virtual or small company environment preferred.
  • Advanced knowledge of Quality Assurance principles, concepts, industry practices and standards including combination products, ISO standards and ICH guidelines.
  • Proven ability to interact with stakeholders to define objectives and priorities within the scope of the project/program/initiative.
  • Successful track record with health authority inspections and audits.
  • Proven ability to develop detailed project plans including milestones, timelines, corrective actions to problems or issues, anticipation of problems, and facilitation of scope
  • Stellar track record in managing third parties including external contract research organizations and manufacturers. Familiarity with line management and project management, embracing budgets and timelines.
  • Successful track record of selecting, implementing, and optimizing electronic quality management system software including modules for document control, complaints, nonconformities, CAPA, and other Quality System functions.
  • Strong technical expertise in chemical process development, formulation, quality, API and drug product, regulatory, clinical, fill finish manufacturing, packaging and
  • Ability to interpret scientific data, as well as write and understand routine and technical documents.

Competencies:
  • Self-starter, Effective & Strategic Leadership, Skilled Communicator, Team Developer, Excellent Judgement, Complex Problem Solving, Highly Organized, Detail Oriented.
  • Ability to travel both domestically and internationally.
  • Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.

Meet Your Recruiter

Tracey Goldthwaite
Senior Vice President

Tracey spearheads the firm’s Commercial practice and focuses on identifying and placing individuals in leadership roles within Global Marketing, Medical Affairs, New Product Planning, and Patient Advocacy and Engagement, to name a few. With 25 years of experience, she also plays a key role in the Clinical Staffing practice, recruiting top talent of all levels for positions in our core areas including Clinical Operations and Development, Regulatory Affairs, Pharmacovigilance and Program Management.

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