Essential Functions
- Adopt
and implement the global Quality Management Plan within the scope of the
assignment; this will include:
- Planning
and executing the Quality Management activities;
- Risk
identification and assessment through data review and quality control
processes;
- Providing
support in risk mitigation, in planning corrective/preventive actions, and
guidance for improvement;
- Supporting
the assigned business line management and staff to enhance effectiveness.
- Cooperate
closely with the relevant business and other stakeholders, support
maintaining focus on quality in project delivery.
- Contribute
to the development and implementation of a Delivery Unit/Sponsor specific
Quality Management plan and Risk Management Program, monitor the
implementation and delivery.
- Provide
advice and support to teams within the assigned business line and other
key stakeholders on all aspects of Good Clinical Practice (GCP)
compliance.
- Work
in close cooperation with teams to manage non-compliance, quality issues,
assist in planning corrective/preventive actions, as applicable according
to SOPs.;
- Inform
the assigned business line and Quality Assurance of quality issues
according to SOPs.
- Work
closely with Quality Assurance and assigned business staff in case of
suspected misconduct, as required by the applicable SOPs.
- May
provide assistance during audits and regulatory inspections to the teams
to the extent agreed, as required by the applicable SOPs.
- Prepare
periodic reports to stakeholders on quality related matters, risk
assessments and specific quality improvement initiatives.
- Upon
agreement the line manager: Perform any other reasonable tasks as required
by the role.
Qualifications
- Bachelor’s
Degree
- At
least 3 years relevant experience in Quality Management (not in the
manufacturing industry)
- Sound
working knowledge of medical terminology, International Conference on
Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory
requirements, quality management processes.
- Knowledge
of National and International Regulations and Drug Development processes.
- Knowledge
Pharmaceutical industry operations.
- Good
organizational, interpersonal and communication skills. Good judgement and
decision-making skills.
- Strong
influencing and negotiation skills.
- Strong
computer skills including Microsoft Office applications.
- Excellent
problem solving skills.
- Ability
to travel within the region/country.
- Ability
to lead and motivate a team.
- Ability
to establish and maintain effective working relationships with co-workers,
managers and clients/customers.
How to
Apply
