Would you like to play a crucial role in developing life-saving therapies? Are you excited to use your scientific insight to partner with internal teams, and external partners as we strive to cure unmet medical needs?
We are looking for a Medical Affairs Quality and Compliance Director who is ready to support our Medical Affairs department. You will work with our Medical Affairs teams, and other functional areas as necessary, around the globe to provide support for compliance with the post marketing regulated activities they undertake, including but not limited to the following: non-interventional and real world evidence clinical research, medical information service, support for implementation of local labelling and management of risk minimization materials.
You will also work closely with teammates across R&D Quality and Compliance and other quality groups responsible for quality oversight of Medical Affairs.
We need someone with strong leadership skills, expert knowledge of Medical Affairs post marketing requirements, preferably experience with pharmacovigilance as well as late phase clinical research, audit skills, communication, and facilitation skills, and the ability to manage multiple projects. You will be a part of an expert and supportive team that fosters constructive collaboration in support of our Medical Affairs post marketing activity.
Lead and/or coordinate Medical Affairs compliance activities. Handle multiple projects and ensure overall and timely completion of tasks.
Works closely with compliance staff and Medical Affairs to provide expert compliance information, manage identified issues, and support continuous improvement.
Responsible for ensuring the development of audit plans and ensuring timely execution of plans for assigned programs. Collaborate and provide input into other audit programs (including affiliate and vendors) which support Medical Affairs compliance.
Oversees routine and complex internal audits.
Support deviation identification, reporting, and CAPA development
Supervise, develop, train and manage internal staff as required.
Ensure oversight of contract auditors.
Undertakes effective compliance reporting to Quality and Compliance senior management and cross functional leadership
Leads Medical Affairs quality governance forum and provides input to other quality forums as required.
Leads intra/inter-departmental teams and/or projects that support preparing the Company for minor changes in regulations and continuous improvement of the Quality Management System. Builds positive support and acts as role model for change.
Represent Quality and Compliance in cross functional Working Groups as required
May lead/support management of regulatory inspection activities such as readiness preparation, inspection management, and/or response management.
Fosters a commitment to quality in individuals and a culture of quality within the organization.
10-12+ years of relevant experience and a Bachelor's degree in a relevant discipline.
10+ years of relevant experience and a Master's degree, or equivalent, in a relevant discipline.
8+ years of relevant experience and a PhD or equivalent
Must have significant Medical Affairs compliance support experience. Direct experience supporting PV and GCP activities preferred.
Bio-pharma sponsor or CRO experience required.
Recognized as an expert resource on a range of compliance topics.
Strong verbal and written communication skills and interpersonal skills.
Proficient in Microsoft Office suite. Experience with audit management/CAPA management programs strongly preferred.
Excellent organization skills and project management.
Able to work equally well as part of a team or independently
Ability to travel approximately 25% required