Director of Quality Assurance Operations

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Description

Position Summary:

• Oversee all aspects of the Quality Assurance Operations team ensuring compliance with internal procedures, industry regulations and regulatory requirements.
• Collaborate with a cross functional team to drive a quality culture that prevents future deviations through a robust and proactive investigation process.
• Accountable for implementation and maintenance of quality assurance operations strategy, framework, methodology, infrastructure, and procedures to ensure compliance with regulations.
• Ensure that the Quality System meets standards expected by US and other applicable global regulatory authorities for research, development, and commercial activities.
• Performs and assists with additional work duties or responsibilities as assigned or apparent.
  
  

4500 12th Street Extension, West Columbia, SC 29172

• Phone: 800.443.4313
• nephronpharm.com
  
  

Primary Accountabilities

NOTE: The primary accountabilities and the knowledge, skills and abilities listed below, are intended to describe the general content of and requirements for this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

• Provide operational strategies to address compliance gaps or determine enhancements to cross-functional quality systems.
• Ensures compliance with all current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), as well as all applicable company compliance guidelines, standards, and objectives.
• Review and approval of new product risk assessment, equipment cleaning verification/method qualification documents, and related supporting documents.
• Responsible for providing QA oversight of internal process and cleaning validation activities and evaluation of process being in a state of control.
• Responsible for review/approval of validation protocols and reports
• Participate in inspection readiness activities and provide support during regulatory site inspections. Provide post-inspection support to address any regulatory observations.
• Support inspections by FDA, other regulatory agencies, and company’s commercial partners.
• Manage QA operations investigations in an effort for timely completion, maintaining electronic files, updating procedures as required, etc.
• Responsible to assure compliance with FDA regulations in the areas of non-conformance investigations, planned deviations, or corrective and preventive actions (CAPAs) at Nephron Pharmaceuticals Corporation.
• Partner with the Quality Management to provide leadership and guidance on investigation governance across all business functions.
• Partner effectively with other functional leaders and site Managers to develop and maintain a meaningful and robust Quality culture across all aspects of the business.
• Work collaboratively with quality investigations team with attention to repeated occurrences of similar root causes.
• Engages with site teams to review Quality Performance metrics and recommend actions for continuous improvement
• Design, implement and maintain GMP QA and QC programs related compliance infrastructure, including SOPs, training systems, and activities.
• Assess functional and organizational competencies, address gaps, plan and implement solutions.
• Ensure all regulatory commitments are adhered to and be proactive with regulatory and industry changes.
• Responsible to assure compliance with FDA regulations in the areas of non-conformance investigations, planned deviations, or corrective and preventive actions (CAPAs) at Nephron Pharmaceuticals Corporation.
• Assure hiring decisions and quality of hires address QA strategic and functional needs of the company; advocates for resources when needed.
• Mentor and develop competencies of QA team members.
• Facilitate and oversee the responses to audit and inspection observations as appropriate. In addition, work with the team to analyze data across product areas to identify signals and trends and will then develop and implement appropriate process improvement strategies.
• Communicate significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Executive Management.
• Develop, analyze, and report quality metrics (e.g., key quality performance metrics) and highlights regarding Quality function.
• Assesses and provides input to strengthen company programs/strategies with an aim to increase Inspection Readiness.
• Work with colleagues to instill a sense of ownership and commitment to quality.
• Optimize the QA work of the team by helping to guide and strategize day-to-day tasks.
• Provide technical support to the leadership team in the decision-making process.
• Salary range: Based on experience.
  
  

Knowledge, Skills & Abilities

• Bachelor of Arts or Science degree with 15 years of pharmaceutical or FDA regulated industry experience; Advanced degree (MS, PhD, MBA) preferred.
• Must have in-depth knowledge of FDA guidelines and have a proven track record in implementing these guidelines in fast growing environments.
• Significant work experience in a pharmaceutical, cGMP environment is required, strong working knowledge of FDA requirements and guidance documents.
• Experience in evolving cGMP related quality systems, policies, and procedures to ensure compliance with evolving standards as well as improving the efficiency of related workflows.
• Comprehensive knowledge of quality system requirements such as US FDA GMP, GCP, EMA, and ICH guidelines and has a proven track record of successfully implementing these requirements to ensure patient safety and compliance with FDA and other applicable health authorities’ requirements.
• Excellent written and oral communication skills.
• Team player and must be able to interact with all departments.
• Ability to work independently and be dependable.
• Ability to manage, train, motivate, and discipline employees.
• Technical writing skills required
• Strong attention to detail.
• Incumbents are required to wear specified protective equipment as necessary.
• The ability to identify work elements in detail, and develop work standards, and work method improvements; develop procedures, and forms to effect method improvement and work simplification.
• Specific expertise, skills, and knowledge within Quality Assurance gained through education and experience.
• A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.
• The ability to take strategic objectives and accept accountability to drive results through effective actions.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• The ability to set clear targets and use performance measures to assess risk and opportunities to effectively manage the assets of the business.
• The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
• The ability to effectively manage oneself, demonstrates integrity, be productive under pressure, and achieve development goals.
• The ability to manage a multitude of resources and to be accurate and current with data and information.
• Position requires lifting (up to 40 lbs.), vision (20/20), standing (10%), sitting (40%), walking (50%), talking, typing and hearing
  
  

EEO Statement

Nephron is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, gender identity, age, national origin, disability, status as a protected veteran, pregnancy, marital status, genetic information, childbirth, medical needs arising from pregnancy and childbirth and related medical conditions, including lactation, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.