Senior Director – Quality, GMP and Investigations

The Senior Director – Quality, GMP & Investigations is responsible for directing and coordinating quality assurance activities for clinical supplies and commercial product CGMP responsibilities and investigations related to product complaints and non conforming events. This individual ensures compliance to the FDA and other worldwide health authority CGMP regulations and guidelines, site SOPs, protocols, and industry standards, as applicable.

*Essential Duties and Responsibilities include the following. Other duties may be assigned.

•Reviews product complaints received for marketed products.  Identifies product complaints that meet field alert reporting requirements and participates in internal review by the Heads of Quality, Regulatory, and Technical Operations and including the Head of Drug Safety and Risk Management and Clinical Development and Medical Affairs, as appropriate.

•Oversees review product complaint information or non-conforming events, to in-house client staff and, if appropriate, to the responsible individuals at service providers.

•Directs the GMP audit function.

•Oversees and provides assessment of and recommends corrective and preventative action of investigations and ensures implementation of corrective and preventative actions.

•Plans with appropriate subject matter experts both internal and external, and conducts domestic and international service provider inspections related to field alerts and non-conforming events.

•Participates in decision making related to field alerts and recall activities.

•Applies and ensures GMP and Investigations staff follows departmental SOPs.

•Reviews internal and external SOPs as related to CGMP activities and investigations and provides final Quality approval of internal SOPs.

•Ensures that metrics and trends as well as compliance issues and their resolution are tracked on a periodic basis and presents metrics and trends to the Quality Committee.

•Leads Process Improvement teams.

•Acts as a key point of contact for staff, providing information and expert guidance on regulations and procedures.

•Ensures Quality documentation files, databases and logs are maintained.

•Ensures project deadlines and performance standards are met.

•Ensures compliance with all of policies and procedures including safety rules and regulations.

•Participates in and may lead compliance inspections conducted by external sources (i.e. health authorities) , as applicable.

•Evaluates corrective and preventative action responses to audit findings for adequacy and timeliness and ensures timely and effective close-out of these actions.

•Provides ongoing feedback, development and performance reviews of staff.

•Assists with talent recruitment and leads a highly motivated, efficient and effective team.

•Responsible for training and mentoring associates in the Quality department.

 

Education and/or Experience:

•Bachelor’s degree in life sciences or related field required.

•Master’s degree in life sciences or related field preferred.

•Minimum of ten years experience in the regulatory compliance environment.

•Minimum of nine years auditing experience in CGMP regulated industries required.

•Minimum of five years management experience.

•Prior experience with pharmaceutical and biological products as well as with medical devices preferred.

•Prior domestic and international experience preferred.

 

Supervisory Responsibilities:

•This individual supervises directors, managers and auditors in the Quality department.

 

Qualifications:

•Expert knowledge of CGMP and investigation conduct concepts.

•Strong knowledge and understanding of the approach and perspectives of regulatory agencies.

•Must be able to interpret and apply CGMP regulations and guidance’s independently.

•Extensive knowledge of FDA, EMA and ICH CGMP requirements regarding CGMP (clinical supplies and commercial product), product complaints, field alerts, and investigation.

 

Computer Skills:

•Must be proficient in MS Office Suite.

 

Certificates, Licenses, Registrations: none required

 

Other Skills and Abilities:

•Excellent writing, communication and presentation skills.

•Ability to manage both day-to-day operations as well as project work in a fast paced environment.

•Ability to work both independently and in a collaborative team setting.

•Ability to multi-tasks and adjust priorities, as necessary.

•Ability to effectively present information to management.

•Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.

•Demonstrated leadership and project management skills.

 

Physical Demands:

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

•The average travel for this position is 25% with some variation based upon the demands of the business imperatives. Travel is to both domestic and international locations in support of audit activities.