Director of Quality

 

Position Title: Senior Director of Quality

Position Type: Full Time

Job Type: Experienced

Reporting To/Department: Chief Executive Office

 

 

Summary

 Lumicell is seeking a highly motivated Senior Director of Quality to work in a dynamic, fast-paced start-up environment. This is an exciting opportunity to join a company that has received excellent press and generated promising clinical data while still in its early development. The successful candidate is a self-initiating and independent problem solver who integrates well into existing company processes and helps promote the company’s collaborative culture. The ideal candidate has leadership experience in both the Pharmaceutical and Medical Device industries.

 

The Senior Director of Quality must have a good understanding of quality systems to meet applicable requirements of cGMP and ISO standards, particularly 21 CFR Part 820, 21 CFR Part 210/211 and ISO 13485. They should have experience in setting up manufacturing sites; including quality management system development and implementation to support the full product life-cycle, from feasibility through commercial release and field support. The successful candidate will have a working knowledge of risk management principles and be familiar with fundamental requirements of ISO 14971 and ICH Q9 compliance.

 

Responsibilities:

  • Provide Quality Assurance and Quality Engineering support for product design control of Class III devices that include software and hardware within quality, time and budget constraints.
  • Organize, manage and be a key contributor to the product Design History File and supporting data for NDA, PMA and other regulatory filings.
  • Execute the role of both quality oversight as well as a hands-on contributor supporting multiple indication development initiatives.
  • Ensure compliance with all laws, regulations, and guidance applicable to pharmaceutical drug manufacturing together with the fulfillment of company’s business objectives.
  • Provide leadership and guidance throughout the organization as the primary champion of GMP and pharmaceutical regulatory compliance.
  • Participate and contribute as an active and dynamic member of the company’s executive team.
  • Participate in the review of customer, supplier and service provider contracts and supply agreements.
  • Negotiate and approve quality agreements with customers, suppliers, and service providers.
  • Represent company during customer visits, GMP audits and regulatory agency inspections.
  • Stay abreast of developing GMP and other regulatory requirements and pursue continuous improvement throughout the organization.
  • Create and implement best practice quality vision, strategy, policies, processes and procedures to aid and improve business performance.
  • Implement and monitor all Quality Assurance systems to ensure compliance with ISO, FDA, ICH and EU directives/requirements.
  • Maintain the Quality Risk Management system to assure that risks are adequately controlled as per current requirements.
  • Drive continuous improvement activities to ensure problems are prevented and issues resolved efficiently and economically.
  • Ensure that Quality meets or improves on budget, cost, volume and efficiency targets (KPIs) in line with business objectives.
  • Promote collaboration and transfer of best practice across Quality Operations and the broader organization.
  • Liaise directly with Federal Drugs Administration (FDA), notified bodies and other regulatory agencies.
  • Evaluate the challenges faced by the business and take action to mitigate risks and develop opportunities.
  • Develop the technical, GMP and leadership skills of direct reports, including performance reviews.
  • Counsels, trains, and interprets quality requirements to ensure we and our GxP vendors maintain a state of compliance.
  • Communicates significant quality risks that may impact product suitability or regulatory compliance in a timely manner to our Executive Team.
  • Serves as an escalation point for corporate quality issues.
  • Provides leadership and mentorship of the Quality team. Plans and oversees day-to-day activities of the Quality function including management of consultants/auditors as needed to ensure project and business needs are met.

Qualifications:

  • Degree in science discipline (chemistry, biochemistry, chemical engineering, biology, or similar)
  • Experience of 10 years in pharmaceutical or medical device industry
  • Experience of 5 years in GMP Quality Assurance
  • Extensive experience in supervisory role
  • Experience in regulatory inspections
  • Background in analytical science
  • Creativity to solve technical and compliance problems
  • Ability to create and maintain a spirit of teamwork
  • Ability to set priorities and to follow through on commitments
  • Ability to meet deadlines under pressure
  • Strong leadership and supervisory skills
  • Strong organizational skills
  • Excellent communication and presentation skills

 

Supervisory Responsibility:

  • This position has supervisory responsibilities over other managers.

 

Work Environment:

  • This job operates in a professional office environment. This role routinely uses standard office equipment such as laptop computers, photocopiers, and smartphones.

 

COVID Policy

  • Lumicell has an implemented and strictly enforced COVID Policy that’s intended to keep all employees safe when working on-site. Our policy mandates: restricted number of employees on-site at a time, a socially distanced and protected seating structure, mandatory mask-wearing, and daily cleaning & disinfection of all communal areas.
  • Employees are given full flexibility to be able to work on-site and remotely in order to help limit the amount of person-to-person exposure. On-site vs. remote working percentages will depend on the individual’s responsibilities and project needs.
  • Lumicell has also created an internal COVID Task Force to stay up to date on all COVID developments and to adjust our policy appropriately based on such information.

 

Position Type/Expected Hours of Work

  • This is a full-time position, 40 hours per week. Days and hours of work are Monday through Friday during business hours.  Occasional evening and weekend work may be required as job duties demand.

 

Travel

  • Some travel may be expected for this position including internal meetings, conference and or training events.

 

EEO Statement

  • Lumicell is an equal opportunity employer

 

Other Duties

  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

To apply for this position, please send your resume to careers@lumicell.com.