Sr. Quality & Compliance Specialist (Remote, US)

POSITION SUMMARY

The Sr. Quality & Compliance Specialist assists the Quality & Compliance leadership with the oversight and direction of quality and regulatory compliance at assigned divisions and with developing, executing, and maintaining Anju’s Quality Management System – companywide and/or at the assigned division(s). The Sr. Quality & Compliance Specialist works in unison with Specialists 1 and II to manage the Quality & Compliance department’s orientation of all Anju new hires companywide. As such, the Specialists are the first impression of Quality & Compliance to the new hire, the Sr Specialist must be highly professional, well versed in Anju’s policies, procedures, and work instructions, and be able to communicate effectively across all levels within the organization on a wide variety of topics with diplomacy and tact. The Sr. Quality & Compliance Specialist will be actively involved in and assist with regulatory compliance companywide; therefore, they are expected to have a solid understanding of the regulations that govern Anju’s applications. The Sr. Specialist will assist department leadership with key activities needed to assure the successful execution of Anju’s key regulatory compliance programs including FDA, ICH-GCP, 21 CFR Part 11, General Data Protection Regulation (GDPR) and other regulations involving privacy and data protection, and other applicable international regulations. Additionally, the Sr. Specialist will review validation deliverables of assigned Anju application developments prior to release, assist in the administration, creation and processing of quality and compliance documentation, e.g., training and profile materials, corrective and preventive actions, deviations, memos to file, documentation requests, and the assessment of supplier systems/tools. The Sr. Specialist will also conduct internal, vendor and client audits and coordinate resulting corrective action activities.

PERSONAL QUALITIES

Professional; excellent work ethics; commitment to high quality standards, attention to detail, excellent communication, interpersonal, organizational, and presentation skills; excellent time management skills, and proven talent for seeking and implementing solutions; methodical work approach with ability to be flexible combined with ability to prioritize and multi-task; self-starter; ability to work independently or within a team as well as within a collaborative, collegial, multidisciplinary environment.

QUALIFICATIONS NEEDED

• Degree level education in a relevant field plus a minimum 4-6 years’ experience in a Quality Management, Auditing or Compliance role with a pharmaceutical company, healthcare software company, and/or relevant experience performing the activities listed above.
• Must possess relevant Quality Assurance/Management and Compliance experience preferably in the medical/pharmaceutical/ biotech software industry. Experience with hosting audits preferred.
• Strong knowledge and understanding of GCPs, FDA regulations, quality assurance concepts, SOPs, and auditing techniques. Knowledge of 21 CFR Part 11, GxP, GDPR, and other privacy regulations preferred.
• Proficient with MS Office applications. Prior experience with quality management system software and/or software development in a regulated industry a plus.

SKILLS NEEDED

• Possess the ability to promote quality achievement and performance throughout the organization.
• Ability to liaise with customers and auditors to ensure compliance with customer’s specifications and the execution of corrective action when required.
• High degree of comfort interacting with auditors. Able to take a lead role in facilitation of client audits.
• Ability to work within and/or lead a team, establish direction, and motivate and inspire team members.
• Possess the ability to promote quality achievement and performance throughout the organization.
• Ability to liaise with customers and auditors to ensure compliance with customer’s specifications and the execution of corrective action when required.
• High degree of comfort interacting with auditors. Able to take a lead role in facilitation of client audits.
• Ability to work within and/or lead a team, establish direction, and motivate and inspire team members.

RESPONSIBILITIES

• Assist department leadership in activities supporting the development, implementation, training, maintenance, and improvement of Anju’s Quality Management System (QMS) and regulatory compliance.
• Assist and/or lead department leadership in corrective and preventive action activities including deviation management and memos to file.
• Oversight, review and approval of validation or qualification deliverables for assigned applications.
• Ensure all assigned divisions and departments have documented procedures and work instructions in place for all critical functions.
• Perform internal audits for adherence to policies/SOPs/regulations/project specifications.
• Perform vendor audits as assigned.
• Administer assigned department business applications including terminating access per procedure and timelines.
• Inform department leadership of any non-compliance incidents or regulatory compliance issues, which may arise internally, or with customers, vendors, or contractors.
• Assist department leadership in conducting internal investigations of compliance issues.
• Communicate with the Quality & Compliance Team regarding quality or compliance issues.
• Develop, maintain, and present new hire Quality & Compliance Orientation Training, ensure CVs, eSignature pages and Job Descriptions are in place per SOPs.
• Prepare and compile QMS training records in support of audit activities. Ensure all training completed outside of the QMS application is assigned and/or documented as appropriate.
• Must be able to independently mage and host client audits. Prepare or assist with documentation requests and arranging interviews. Prepare external audit response and provide corrective action status reports to clients.
• Oversee all customer and internal documentation requests including providing access to and removal of access (Box.com, HQ and internal SharePoint e.g., client-facing).
• Respond to all questionnaire requests received from Anju client facing staff or similar. Engage SMEs.
• Develop, deliver, and/or manage quality and compliance related non-procedure training.
• Obtain, review, and document vendor annual SOC2 reports.
• Perform regulatory and system assessments, as applicable, for Anju products and supplier tools.
• Work with VP and leadership team to ensure compliance adherence across the organization. Actively gain/increase knowledge of GxP, 21 CFR Part 11, HIPAA, GDPR, and other regulations that impact Anju’s core business and products.
• As requested, participate in Quality & Compliance Committee (QCC) activities as a guest; assist QCC Chair with preparation and coordination of meetings, agendas, minutes, reports, presentation delivery, and action items, as requested.
• Mentor Quality & Compliance Specialists I and II and/or any other assigned staff.
• Other duties as assigned.