DIRECTOR OF QUALITY AND REGULATORY AFFAIRS JOB DESCRIPTION:

The Director of Quality and Regulatory Affairs will lead our Quality and regulatory compliance efforts for Summit SD’s pharmaceutical distribution operations. This critical role ensures that our distribution practices align with regulatory requirements and Quality standards while safeguarding the integrity of the pharmaceutical supply chain. Responsibilities include overseeing Summit SD's operations in the areas of Quality, accreditations, regulatory compliance, and adherence to industry standards. This role requires significant collaboration with other departments to ensure Summit SD abides by the required standards from authoritative bodies, accrediting organizations, and contractual obligations.

Job Responsibilities and Essential Functions

• Establish, maintain, and improve Summit SD’s Quality Management System (QMS) to comply with international GDP standards.
• Serve as Summit SD’s Quality Manager (QM) and head of the Quality Improvement (QI) Committee.
• Document creation, finalization, publishing and archival, adhering to the requirements of all authoritative and accrediting bodies.
• Ensuring published documents are up-to-date and reflect current processes and procedures.
• Oversee internal and external audits, studies and validations, ensuring continuous compliance with the required Quality standards.
• Manage, investigate, and monitor Quality incidents, deviations, and complaints, driving resolution and preventive action.
• Provide strategic input to executive leadership on Quality and regulatory risks and opportunities.
• General oversight of Summit SD's operations in the areas of Quality, accreditations, regulatory compliance, and adherence to industry standards.
• Monitor, interpret, and communicate changes in state, national, and global regulatory requirements, ensuring timely updates to company policies and procedures.
• Work closely with the Business Administration Department to ensure the organization maintains current and appropriate required state and federal licensure as it relates to the distribution, importation, and exportation of prescription drug.
• Work closely with the Operations Department to ensure all operations and documentation meet the all applicable GDP, accreditation, and legal standards.
• Work closely with the Information Technology department to ensure compliance in system operations including but not limited to: risk analyses, change management and adherence to FDA’s 21 CFR Part 11.
• Lead interactions with regulatory and accrediting agencies, including submissions, inspections, document preparation, and communications.
• Serve as the point of contact between the executive leadership team and outside counsel.
• Provide initial and ongoing Quality training to personnel.
• Any other tasks or projects that relate to the company’s Quality, accreditation, or regulatory compliance operations.

Required Qualifications

To perform this job successfully, an individual must be able to satisfactorily perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/ or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor’s Degree required.
• Must have a minimum of 3 years of experience in Quality in the pharmaceutical, or other FDA regulated industry.
• Proficient Computer Skills: Familiarity with office software (e.g., Microsoft Office Suite products & Adobe Acrobat)
• Strong verbal and written communication skills.
• Exceptional skills in the following:
  • Organization: Ability to maintain an organized workspace, manage files, and keep track of appointments and schedules.
  • Time management: Skilled in prioritizing tasks to handle multiple responsibilities while maintaining a smooth workflow.
  • Effective communication skills: Ability to clearly convey information, listen actively, and engage with clients and colleagues effectively.
• Must possess strong customer service and leadership skills, including high skillsets in the following: self-awareness, organization, relationship-building, empowering others, presenting yourself as constant and consistent, and serving as role model for others within the team and organization.
• Additional required skillsets:
  • Adaptability: Flexibility to adjust to changing situations and handle unexpected challenges with ease.
  • Attention to Detail: Ability to notice and manage small details, which is crucial for maintaining accuracy in administrative tasks.
  • Multi-tasking: Capacity to handle multiple tasks simultaneously without compromising quality or efficiency.
  • Problem-solving skills: Capacity to address issues or concerns quickly and efficiently, often on the spot, and develop practical solutions.
  • Interpersonal Skills: Strong ability to build rapport and maintain positive relationships with diverse individuals.
  • Professionalism: Maintaining a courteous and respectful demeanor, reflecting the company's values and standards.
  • Teamwork: Willingness to collaborate with others and support team efforts to achieve common goals.
  • Emotional Intelligence: Understanding and managing one’s emotions and the emotions of others to enhance communication and relationships.

Physical Requirements and Screenings

• Physical Demands: The physical demands described here are representative of those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • This role can be either a remote or in-office role. If the position is remote, regular travel to our Lee's Summit, Missouri location is required. The employee is expected to be available during regular business hours.
  • While performing the duties of this job, the employee is regularly required to sit and talk or hear.
  • The employee is frequently required to stand, walk, use hands or fingers to handle, or feel and reach with hands and arms.
  • Specific vision abilities required by this job include close vision and ability to adjust focus.
• Mathematical skills: Ability to solve simple math problems and analyze numbers as they relate to necessary job functions.
• Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Logic and Interpretation: Must have the ability to read and accurately interpret laws, rules, regulations, and standards as it relates to the position.
• Background and professional reference screenings are required.

Travel and Work Location

• Availability during regular business hours and frequent travel to our facilities (if remote) is required to allow for the highest level of collaboration with other departments.

The job description and list of duties indicated above is not comprehensive. Duties, responsibilities, and activities may change at any time.