Head/Director of Quality

Essential job functions:

Drive an organization wide culture of Quality by enabling a Quality by Design approach and by establishing effective design & implementation of our Quality Management Systems (QMS) including standard operating procedures (SOPs), Enterprise Quality Management Software (EQMS), Work Instructions (WIs), Quality Controls and communications with certifying authorities.

Quality Assurance

Develop and create Quality infrastructure and strategic direction in conjunction with Product Development, Supply Chain Operations and Regulatory.
Ensure that QMS meets the applicable FDA, State & Local Health, FSMA requirements and FSSC (ISO) 22000 requirements.
Optimize quality management systems, processes and procedures including change control, document control, risk management, deviations, CAPA, training, product complaints, raw material / CMO supplier audits, and vendor qualification in line with 21 CFR 111 guidelines.
Lead the development and reporting of Quality metrics and periodic reporting depicting KPI compliance requirements to include trending and any areas of risk with associated mitigation plans.
Coordinate and host all GMP and FSSC (ISO) 22000 inspections.
Prepare for and successfully close GMP and FSSC (ISO) 22000 audits certifying bodies.
Provide guidance on GMP compliance matters as part of commercial leadership team and within core project teams.
Establish and maintain adequate GMP training programs to support aggressive 5-year growth plan.
Serve as an escalation point for quality issues including investigation, recalls, deviations, CAPA, change controls, audits, validation and training.
Ensure that the company, its contractors and vendors are prepared for FDA and other Health Authority audits..
Develop plans and programs to support continuous quality improvement.
Develop and effectively manage department annual operating budgets for Quality.

Quality Control

Oversee the development, implementation and review of QC procedures and policies related to vendor cGMP operations. Collect and archive vendor cGMP documentation in a timely manner.
Ensure that QC analytical methods and laboratories are qualified,
Help Product development align test methods between suppliers and their labs with those Specifications.
When necessary, support the development of analytical methods.
Work with key Quality and cross-functional stakeholders to develop execution plans for increasing capacity and throughput of QC operations, with aim of providing safety and quality of the product while developing methods that may result in reduced testing costs.
Collaborate to identify and mitigate risks in QC operations that could negatively impact customer satisfaction and Quality metrics.
Support organizational drive to implement process & systems improvements increasing quality and productivity.

Quality Leadership

Provide exceptional leadership skills to the organization including hiring, mentoring and developing QA and QC staff.
Develop a vision, strategy, and plans that are innovative, forward-thinking and based on sound business judgement, considering scalability and sustainability.
Use strong communication and teamwork skills to build strong relationships with stakeholders.
Champion implementation of new technologies and systems.
Ensure a culture of strong GMP compliance and risk management.
Role model of core values and Quality by Design principles to drive continuous improvement.

Secondary job duties:

Other Duties may be assigned.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education:

Must have a bachelor’s degree in a life science-related field (such as biology, biochemistry, nutrition, pharmacy, food science, etc.), or
Science or Engineering-related degree (health, food engineering, bio-medical, etc.), or
an equivalent combination of education and experience.

Experience:

Minimum 10 years work experience in a Quality Management position in a manufacturing environment preferably within Dietary Supplement or Pharmaceutical industries.

Skills & abilities:

Understanding of Quality Management and experience with implementing FDA regulations.
Implementation of 21 CFR 111 regulations in a GMP environment across certifying bodies (e.g. FDA, other third parties (NSF, SGS, USP, etc.)) and any other US and external-US certifications (e.g. TGA, Health Canada, EU, etc.).
Is experienced at communicating with certifying authorities, raw material and CMO suppliers and testing labs. Regulatory and product development experience is a plus.
Implemented, participated in, or has relevant experience with implementing Quality Management Systems leveraging a Quality by Design approach, needs to be familiar with FSMA, FSVP, HACCP, HARPC, QbD, six sigma and certifications preferred.
Has expertise and experience in designing, writing and implementing Standard Operating Procedures (SOPs) and Work Instructions (WIs) that are simple, scalable and compliant.
Has successfully implemented or optimized an Enterprise Quality Management Software (EQMS) in a complex organization (preferably SAP environment).
Has knowledge of Quality Control including analytical methods for natural ingredients (e.g. Botanicals, probiotics) and Laboratory Information Management Systems (LIMS).
Has subject matter expertise across GMP, Quality Assurance, Quality Controls and Regulatory Affairs.
Excellent written and oral communication skills.
Leadership - Is wired for speed, accuracy and inspiring compliance. Is a skilled facilitator and problem solver. Has flexibility to be both hands on and coach.
Team Oriented – being helpful, respectful, approachable, building strong working relationships and a positive work environment, dependable, honest, interacts with others tactfully, resolves conflicts appropriately and adapts to change.
Has worked in a manufacturing environment, working with internal or external laboratories, sanitation, and manufacturing teams.

Computer skills:

Experience working with an Enterprise Resource Planning (ERP), or Enterprise Quality Management Software (EQMS) system is strongly preferred i.e. SAP.
Experience Laboratory Information Management System (LIMS) systems and implementation a plus.
Proficiency in Microsoft Office applications, such as Word, Excel, PowerPoint and SmartSheet.

OTHER INFORMATION

Supervisory Responsibilities:

This position supervises the following positions:

Senior Manager of QA, Plant QC Manager and Laboratory QC Manager
In absences of Managers, QA Supervisor and/or QC Supervisor