Director of Quality Management, Austin

POSITION SUMMARY

The Director of Quality Management will develop, implement, maintain, and continually assess Surterra’s quality management program to meet internal company standards and external regulatory and customer requirements.

CORE JOB DUTIES AND RESPONSIBILITIES

Develop, from the ground up, a comprehensive quality management program (including both quality assurance and quality control) for all of Surterra’s operations, including vendor selection and management, cultivation, processing and manufacturing, retail operations, and customer experience.

Implement, maintain, and continually assess and improve Surterra’s quality management program, quality assurance processes, quality control, and internal and regulatory compliance.

Collaborate with Surterra’s leadership team for planning, execution, and oversight of the quality management program and continuous process improvement.

Define, develop, and implement short-term and long-term strategies, goals, objectives, and tactics relating to quality management.

Develop departmental key performance indicators (KPIs) and analyze for opportunities to optimize performance.

Use incident and Corrective and Preventative Action (CAPA) activities and processes to drive quality improvements and respond to process, product, and service issues

Develop, implement, and manage a post market surveillance program to track quality issues in the field.

Develop, implement, and manage a supplier management program for tracking supplier performance, root cause analysis, and corrective and preventative action.

Recruit, train, manage, and lead Surterra’s quality management team.

Build effective partnerships with leadership team and department heads to help drive the business toward achieving company objectives.

Maintain knowledge base of US and international regulations/guidelines for ensuring compliance and providing senior leadership with associated risk assessment and mitigation.

JOB SKILLS AND REQUIREMENTS

10+ years in quality management, quality assurance, and quality control

Prior experience developing, implementing, and managing a quality management system.

Experience in an FDA-regulated industry (including pharmaceuticals, medical devices, or bioprocessing) and aseptic manufacturing is preferred.

Experience with cGMP, cGPL, and/or related compliance programs.

Green belt or black belt trained/certified is preferred.

Ability to work in a fast-paced, changing, and challenging environment.

Analytically and communicatively intelligent.

Focuses simultaneously on short- and long-term goals; ability to identify problems quickly.

Knowledge of customer service, inventory management (including software) and regulatory compliance.

Accurate data-entry and record keeping.

Strong attention to detail, organizational skills and time management abilities.

Ability to pass a background check, including drug testing, to be registered as an employee of a licensed organization in Florida, Texas, and/or other Surterra geographies

Comfort with security protocols, including video monitoring and employee tracking.

An ability to travel up to 25% of the time.

Bachelor’s degree; advanced degree preferred.

PHYSICAL REQUIREMENTS

The ability to lift 20-50 pounds as needed.

The ability to move safely over uneven terrain or in confined spaces.

The ability to perform various physical activities, including lifting, standing, and squatting.

The ability to work in extreme weather.

The ability to wear personal protective gear during portions of the day.

SURTERRA CORE QUALITIES

Be Ethical – Do everything with impeccable integrity.  Be radically transparent, fair and honest with each other.  Do what you say you are going to do.  Be trustworthy.  Avoid deceit, favoritism and discrimination.  Hold people accountable without emotion.  Comply with regulations.  Integrity is a pass/fail quality; you must have it to work with us.

Be a Champion – Always work in the best interest of the patient and the brand.  Empower our patients to find their wellness.  Support their doctors’ recommendations with respect.  Be a constant learner in support of patients’ need for information.  Partner with patients to make the best choices for their well-being.  Fight for their rights to do so.

Be Bold – Be curious, creative and an exemplar of the Surterra brand in all your interactions. Be bold and innovative.  Dream big, take chances.  Investigate and learn with every challenge.  Think three steps ahead and make a plan. Set the strategy and execute against it.   Speed counts.

Be United – Build strong interpersonal relationships based on trust and respect.  Create an inclusive environment where all voices are heard. Listen objectively to opposing views.  Be diplomatic in response to adversity. Always assume good intentions.  Build consensus among competing ideas and personalities.  Be a strong teammate.  Show compassion to everyone.

Be Efficient – Employ a systematic approach to achieve objectives.  Simplify complex and time-consuming activities into simple, efficient actions.  Automate processes wherever possible.  Teach others how to operate within a process.    Never confuse motion for progress.

 Be Well – Organize and operate within a complex and chaotic environment.  Remain calm, poised and effective in stressful situations.  Accept the inevitability of changing priorities and redirect as needed.  Think on your feet.  Be resilient and show grit in the face of challenges.  Avoid taking offense and never be defensive.  Maintain a healthy lifestyle and psychological hardiness.  Set your boundaries and respect the boundaries of others.  Lead by example from the front.

Be Wise – Discern what is appropriate, practical and realistic in any given situation.  Weigh the advantages of competing demands in a regulated industry.  Make decisions that are a win-win for patients and the business.  Say no to good ideas in favor of the best ideas.  Remain open to new information and adapt accordingly.  Use good judgment on appropriate use of limited resources.

 Be Articulate – Show up with confidence.  Communicate with enthusiasm.  Speak and write in a concise, grammatically correct, precise and persuasive manner.  Convey nuances of meaning accurately.  Match styles of communication to each audience and purpose.  Demonstrate executive presence with confidence, decisiveness, dignity and poise.