Program Manager, R&D Quality Assurance, GCP - MA

The purpose of this position is to ensure that clinical trial activities for all assigned projects are conducted in compliance with applicable regulations, Good Clinical Practice (GCP) guidelines, the International Conference on Harmonization (ICH) and Policies and Procedures. In addition, this position is responsible for ensuring that investigator sites, external vendors and internal processes meet quality standards.

The position’s incumbent is responsible for technically complex assignments, accurately identifying and communicating compliance risks, and developing action plans to mitigate risks.
ACCOUNTABILITIES:
Responsible for collaborating with Global Compound Support Quality Assurance function to develop and implement a strategic audit plan for the development of all assigned US compounds. Ensure that activities are conducted and reports written according to applicable regulations and SOPs.
Lead domestic and international audits of clinical investigator sites, documents, databases, vendors (clinical, bioanalytical, and GLP), and internal systems to assure compliance with the Code of Federal Regulations, local regulations, ICH and policies and procedures.

Audits conducted will require advanced auditing skills and will include the most technically complex assignments, including audits of potentially high risk . Assess impact of audit findings on subject safety, data integrity, and business operations.
Obtain audit responses from functional areas and/or vendors, and evaluate proposed corrections, corrective actions, and/or preventive actions for compliance with applicable regulations, guidelines, and policies.

Facilitate risk remediation. Escalate inadequate audit response to senior CQA management.
Lead investigations into scientific misconduct and/or serious breach of GCP. Analyze investigation findings to identify root/probable cause. Propose, document, and track appropriate corrective actions. Assure reporting of potential or confirmed violations, as appropriate, to regulatory agencies.As assigned, review and approve audit reports submitted by Clinical Compound Support Compliance Specialists for content, format, regulatory risks, and compliance with SOPs.

Promote consistent audit report writing standards across function.
Participate in the development and implementation of a comprehensive training program for Clinical Compound Support Quality Assurance. As appropriate, monitor and document Compliance Specialist / Associate Compliance Specialist progress against the training program.
Lead systems monitoring and process improvement initiatives that enhance regulatory compliance and CQA operating efficiency.
Manage audit teams, including outside contractor auditors, to assure compliance with objectives of this position.
Report metrics associated with assigned compounds to QA management, clinical development clinical development staff, and contract research organization staff.

Evaluate if corrective and/or preventative actions are required, and ensure implementation..
Identify potential systemic compliance risks, through audit activities and data analysis, and elevate to immediate manager for immediate and long-term resolution .
Provide GCP compliance interpretation, consultation, training, and other supportive services necessary to maintain and improve the quality of research for timely product applications to worldwide regulatory authorities.

Independently analyze and interpret regulatory requirements as they apply to functional responsibilities.
Develop and conduct GCP compliance presentations at internal and external R& D meetings, facilities or investigator sites as needed.
Provide GCP compliance technical support during regulatory inspections of investigator sites or facilities worldwide to mitigate regulatory action.
Provide on–the-job training to colleagues in areas of expertise.
Contribute to the development, introduction and continuous improvement of CQA systems and processes.
Provide QA input in cross-functional committees responsible for development or revision of procedures.
Demonstrate and maintains proficiency in the knowledge and application of industry standards.

Education &

Experience:

Bachelor’s degree required.
Minimum 7 years of pharmaceutical clinical research or development experience
Five (5) years of quality assurance auditing experience preferred with a minimum of 3 years required
Knowledge and

Skills:

In-depth knowledge of the interpretation and application of FDA and international clinical trials regulations and guidance, and ICH Good Clinical Practice guidelines.
Auditing Knowledge: Demonstrates advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to subject safety and data integrity.
Negotiation

Skills:

Demonstrates proficiency in negotiation and conflict resolution.
Clinical Development: Understands the phases, processes and techniques used to execute a clinical development program.
Product Knowledge: Understands the medical/therapeutic impact of products.
Scientific Knowledge: Possesses the necessary science education and knowledge to manage quality assurance oversight for clinical trials and to assure the ethical treatment of subjects.

Understands medical terminology, standards of care, and disease states.
Communication

skills:

Must communicate professionally, clearly, concisely and consistently to external and internal customers, both verbally and in writing. Must demonstrate professional presentation skills.
Project Management: Must demonstrate proficiency in managing complex projects, delivering all expected deliverable in a timely manner, and proactively communicating changes in pre-established goals and deadlines.
Organizational

skills:

Must be able to prioritize work effectively to meet timelines.
Interpersonal: Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building.
Computer

skills:

Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverable and to communicate with internal and external team members. Must be proficient in use of the Quality Assurance Audit Database (QAAD).
LICENSES/CERTIFICATIONS:
ASQ Certified Quality Auditor (CQA) or SQA Registered Quality Assurance Professional certification preferred.
PHYSICAL DEMANDS:
Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
Carrying, handling and reaching for objects.
TRAVEL

REQUIREMENTS:

Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.
Requires up to 20 % travel.