Senior Director, Quality Assurance
Job Summary & Responsibilities
The Senior Director, Quality Assurance (QA) will be responsible for the development and execution of the global quality organization and quality management system to assure IPM’s compliance with regulations applicable to the development, approval and distribution of microbicides. The Senior Director will assure that QA and global GxP policies and procedures are designed and implemented as required by the applicable regulations for the US, Europe and African countries.
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily:
Lead the development and maintenance of an integrated global quality management system across IPM activities that ensures oversight of compliance with current GxP, regulatory requirements, and corporate policies.
To coordinate with GxP subject matter experts to ensure the IPM management team is fully informed of new GxP requirements and assess impact of regulatory changes on corporate policies
Monitor compliance to regulations and IPM’s procedures and communicate action plans to leadership team
Weigh up and communicate quality and compliance risks as appropriate to IPM leadership
Partner with IPM departments for GxP audits and inspections to foster a proactive approach to compliance
Assure IPM clinical and manufacturing sites are in a state of inspection readiness
Lead quality audits and ensure implementation of improvement plans identified through audits
Represent the IPM Quality Function at regulatory authority inspections and lead development of responses to inspection observations in liaison with SME from respective departments
Assure metrics, goals and priorities are implemented within the quality organization
Assure proper training, mentoring and direction of all QA staff and IPM staff, as appropriate
Other duties as assigned
Requirements:
Job Specifications
Candidates for this position should have the following education/experience and demonstrate mastery of the following knowledge, skills, and abilities:
Education/Experience
Minimum of Bachelor’s degree. Higher degree (Masters, PhD or equivalent) in pharmacy, chemistry or life sciences highly desirable
At least 15 years’ experience in quality assurance, with working knowledge and/or demonstrated expertise in GxP regulations and guidelines and experience in designing a QM system across the organization
Familiar withregulatory issues and inspections with multiple regulatory agencies, including the preparation for, conduct of, and responses to inspections
Knowledge, Skills and Abilities
Strong leadership and negotiation skills
Extensive knowledge in a broad range of pharmaceutical activities and quality systems
Ability to interpret regulations effectively to manage regulatory risks ensuring compliance with GxP requirements
Excellent knowledge of regulations and guidelines pertaining to GxP (e.g. EMA, FDA and African countries) as required
Substantial management experience, including management of employees stationed in remote locations and/or different time zones
Ability to perform effectively in different cultures in a matrix environment.
Excellent written and oral communication skills
Terms and Conditions
Position located at Headquarters in Silver Spring, MD. Up to 20% travel, including international travel required. IPM is an Equal Employment Opportunity employer.
This job description should not be construed to imply that these requirements are the only standards for the position. Other duties will be assigned. IPM has the right to revise this job description at any time. IPM is an “at will” employer and as such, neither this job description nor your signature constitutes any form of contractual arrangement between you and IPM.
