Quality & Training Manager

1. Build & Own QMS

Design and implement a lean, phase-appropriate QMS suitable for academic CRO.

Collaborate with author, review, and maintain Clinical Research Services Standard Operating Procedures/Work Instructions and relevant forms & templates

Establish document control using simple, controlled tools (e.g. SharePoint, controlled folders, basic QMS).

Ensure QMS can withstand sponsor due diligence and early regulatory inspections.

2. Training & Competency

Create and manage training programs, including:

-SOP and process training

-Role-based or Project-based training

Own the department training processes

Develop and maintain training matrices

Ensure department training compliance for all staff by overseeing track training completion and effectiveness using inspection-ready documentation.

Lead the training delivery directly when needed (e.g. onboarding, SOP rollouts) and/or assign appropriate trainers, training sources.

3. Audit & Inspection Readiness

Prepare department for:

-Sponsor qualification audits

-Client due-diligence audits

-Early regulatory inspections (if applicable)

Be subject matter expert for Quality Management

Conduct project quality review, internal process checks, and pre-inspection readiness reviews.

Oversee end-to-end process of deviation management, audit findings, and CAPAs

Act as the primary quality contact during audits

4. Risk-Based Quality & Study Support

Lead risk management process in the department

Apply risk-based quality thinking across all studies

Provide real-time quality advice to Clinical Operations and Project Management

Support protocol-specific risk assessments and study start-up readiness

5. Business & Growth Enablement

Support business development activities by:

-Completing sponsor quality questionnaires

-Participating in bid defenses and feasibility discussions, where needed

Advise leadership on quality implications of:

-New services/vendors

-Compromise site assessment outcome

Ensure quality systems are scalable

6. Culture, Coaching & Leadership

Embed a quality-first but start-up-pragmatic culture

Guide & coach staff on GCP, inspection expectations, and good documentation practices

Lead by example with strong documentation and compliance discipline

Education, Experience and Competencies

Education

Bachelor's degree in Pharmacy, Nursing, or related field such as health science.

Experience

>10 years of experience in Clinical Operations (Pharma or CRO).

Hands-on experience in Quality and Training (Direct or indirect)

Direct involvement in sponsor audits. Regulatory inspection exposure is a plus.

Knowledge of GCP. ISO14155 (optional).

High agility. Able to interact with Health Care Professionals, Key Opinion Leader and Sponsor effectively.

Excellent communication, negotiation and good problem-solving. Able to lead & direct the project team members.

Good written and verbal communication skill with good English.

Competency

Strong working knowledge of ICH-GCP.

Proven ability to:

-Write SOPs independently

-Build simple, inspection-ready systems

-Manage CAPAs pragmatically

Comfortable working with minimal structure and ambiguity.

Strong communication and influencing skills.

Highly organized, detail-oriented, and self-directed.

Experience the use of basic LMS/eQMS tools or controlled document systems, is a plus

Others

Work from home policy is applied

Packages refer to HR