Job Description

Senior Manager - Quality, Compliance and Regulatory Affairs

Who We Are:

Wellthy Therapeutics helps leading Life Sciences Companies upgrade to become Digital Life Sciences Companies. We do this by powering core drug/device portfolios with software-based medicine, deployed via digital therapeutics, companion SaMD solutions, and digital patient support programs, that pair with the drug/device to deliver or enhance treatments for unmet medical needs. Our vision is to impact patient outcomes globally, by using the power of digital health to transform patient care.

Through therapeutic algorithms, our proprietary Wellthy Care - platform personalizes user experience and decision support to optimize engagement and outcomes, and enables software-based medicine that are designed to be used independently or in conjunction with biomedical treatments.

We have secured a number of top-tier life science customers, including announcements with Roche, Cipla, and Ferrer. We have brought several SaMD solutions to market for our partners in Cardiology, Women's Health, Diabetes, Pulmonology & Select Rare Diseases in Europe & Asia, as demonstrated through 25+ real world publications, over 100,000 patients helped, and over 10 million patient interactions & ePRDs collected.

We are a passionate team with first-hand experience building and scaling digital health solutions within the regulated healthcare space, and we are backed by great VCs and strategics.

To read more about us, please visit www.wellthytherapeutics.com

Why the job is important:

Wellthy Therapeutics is looking to add a Quality Lead as a part of our team. This is a pivotal cross functional role that will span across all the functions and will work closely with the leadership team. The primary duties for this position are to administer the quality management system, evaluating and improving the processes, participating as regulatory lead on product releases, stay abreast with industry standards and lead the team.

Culture / Attitude :

- Loves solving complex user problems for multiple stakeholders with success measured on outcomes and results

- Stretches oneself and stretches others to achieve big, audacious goals

- Believes and acts as if speed is a competitive advantage

- Execution and Action bias

- Loves working with cross-functional teams on multiple projects

- Obsessed about solving for health outcomes for individuals, using technology

- Humble & Self Aware

- Encourages and showcases a high amount of empathy

- Measures everything that matters, and encourages team to do the same

- Encourages failing fast, learning and iterating in product development

What will you do:

You possess the ownership and responsibility in leading and ensuring compliance as per the regulations. Coordinate and maintain the regulatory documentation, data maintenance/information systems. Lead the team responsible for verification, validation, risk identification and executing the related activities. The quality management principles, tools and techniques with high levels of business acumen to develop people, processes and associated metrics shall add to the sustenance and improvement of the business. You will be solely responsible for the improvement and maintenance of the quality management system.

Responsibilities:

- Serve as the author and/or process owner of Quality Standard Operating Procedures (SOPs) as assigned to ensure compliance with regulatory requirements

- Single point of contact (SPOC) to control and maintain the SOP repository.

- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to the management for continuous process improvement

- SPOC to create & circulate the quality review calendar to all relevant stakeholders.

- Perform all quality reviews based on the quality review plan of the quality SOP and set up a continuous feedback loop by regularizing the quality huddles

- Escalate major quality gaps on time to ensure timely mitigation.

- Ensure training excellence by building a feedback loop post reviewing of archive training related documents

- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.

- Prepare quality reports at aligned frequency for internal quality management and as required by Wellthy partners.

- Prepare risk register for the company and review the risk management files of cross functional team and support risk management activities including hazard analysis and FMEA.

- Participate and lead internal, external, pharmacovigilance and regulatory audits.

- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.

- Maintain a current knowledge base of existing and emerging regulations, standards, or guidance documents including the Medical Device Directive (MDD), Medical Device Regulation (MDR), and all other standards/regulations included within applicable scope.

- Support and improve company Quality, Information security Systems by creating a quality culture and provide ongoing education on compliance activities.

- Contribute towards accomplishment of departmental and corporate goals and objectives.

- Manage on-going RA tasks such as, but not limited to, Complaint Handling, Change Control, Risk Assessment, Post-Market Surveillance, Corrective and Preventive Actions.

- Administer and manage supplier qualification activities and monitor suppliers' performance of their own respective suppliers and ensure the same is followed and documented by other cross functional teams.

- Provide regular reporting on the current status of the information security program to enterprise risk teams, senior leaders as part of a strategic enterprise risk management program, thus supporting business outcomes.

- Create and manage a targeted information security awareness training program for all employees, contractors and approved system users, and establish metrics to measure the effectiveness of this security training program for the different audiences.

- To prepare the organization with the right tools, skills, resources, relationships and capabilities against growing information security & privacy risks.

- Create a framework for roles and responsibilities with regard to information ownership, classification, accountability and protection of information assets.

- Define needed quality metrics and coordinate data collection from various functions.

- Responsible for Corrective action and Preventive actions (CAPA) closure of all quality reviews. Responsible for support to close the CAPA for certifications & audits

- Compliance to Service level agreement (SLA) defined QMS is recorded & sent at aligned frequency

- Driving automation of Quality Management System (QMS) within the company to improve efficiency & reduce margin for error

- Excellent communication and time management skills to manage multiple projects at any one time

- Should have good clinical & PV process knowledge, ISO 9001, ISO 27001 and 701, ISO 13485, GDPR, HIPAA, PDPA, CE marking, Risk management & BCP & DR, stay abreast with the latest laws and updates on a regulatory & industry best practice front

Authorities: Authorized to

- Create Quality Management, Information Security and applicable regulatory requirements awareness and oversee its implementation in the organization

- Immediate reporting of information security breach or serious threat to the senior management with a resolution

Accountability:

- 100% SOP management (in terms of on time review/ availability/ archival/ transfer/ training

- 100% compliance to the partner quality SLAs

- 100% management on quality review & feedback process & archival of all related documentation

- Timely completion and archival of CAPA & associated evidences

- Passing global and client related audits

- Support in achieving certification to make Wellthy a globally recognized lead in digital therapeutic company

Must Have :

- Experience and knowledge of US Digital Health compliance landscape and Software as medical device regulatory ecosystem

- Hands on with US HIPAA, 21 CFR Part 11 and part 820 audits

- Experience and knowledge of EU Digital Health compliance landscape and Software as medical device regulatory ecosystem

- Hands-on with EU CE Software for medical device filing and managing audits by NoBo.

Skills :

- Strong Leadership, communication, and interpersonal skills demonstrated through projects and interaction with other departments.

- Experience in validating and reviewing documentation

- Strong logical, Analytical and data mining ability.

- Carry a problem-solving attitude,

- Possess high Emotional intelligence,

- Strong focus on the results orientation,

- High on integrity,

- Ability to draft effective procedures to produce the required level of documentation

- Create a strong follow up and closure of the activities

- Demonstrated strong time management skills; able to handle multiple tasks, set priorities and meet deadlines

- Ability to resolve conflicts; work well under pressure, act quickly and decisively using sound judgment

- Compliance driven,

- Highly organized with a strong attention to detail, clarity, accuracy and conciseness

Reporting to - AVP Product

Type - Hybrid

Location - No constraint

Requirements :

- PG Life sciences /Clinical Research /Biotechnology

- 5+ years in Quality Management (preferably for a healthcare based/patient services agency / medical device organisation)