Job title: Sr. Program Manager (Clinical Quality) – 100% Remote
Duration: 6 months (possible Extension)
 
OBJECTIVES:

• Develop and implement the GCP supplier audit plan for clinical development programs, GMA and MPG studies
• Oversee audits for strategic partners and key GCP suppliers; manage and escalate identified compliance risks, ensuring appropriate mitigations are implemented
• Lead and/or participate in GCP sponsor and supplier oversight initiatives.
• Provide professional expertise and leadership in applicable guidance and regulations, proactively identifying potential areas of non-compliance and risk to R&D Business Partners and company

 ACCOUNTABILITIES:

• Provide professional expertise and leadership in GCP guidance and regulations, proactively identifying potential areas of non-compliance and risk
• Develop and implement the risk-based GCP supplier audit and compliance strategy and manage supplier audits in compliance with GCP and policies and procedures. Audits require advanced auditing skills and may involve technically complex assignments. Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to CQA management. Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures
• Provide support as needed for quality governance council meetings
• Liaise and collaborate with internal and external business partners to provide guidance and support pertaining to compliance and supplier quality oversight initiatives
• Analyse audit metrics and develop reports for management.
• Lead investigations into significant quality issues, scientific misconduct and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities.
• Collaborate with Quality Compliance and Systems team to identify and mitigate cross-GXP supplier related quality and compliance issues
• Lead process improvement initiatives as requested by management
• Participate in GCP health authority inspections as required•

 EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelor’s Degree required; Advanced Degree preferred.
• Minimum of 7 years of experience in the pharmaceutical, biotechnology or related health care industry;
• Minimum 5 years GCP auditing or relevant clinical trial experience preferred
• Extensive knowledge and/or awareness of ICH GCP R2 and applicable global regulations and guidance for clinical development
• 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 safety and data integrity.
• Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems
• Effective technical writing skills; able to write quality positions, audit reports, and procedures.
• Excellent communication skills with ability to negotiate and influence without authority in a matrix environment
• Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines
• Superior attention to detail and ability to analyse complex data

 
LICENSES/CERTIFICATIONS:

• GCP Quality Assurance registration/certification preferred

 
PHYSICAL DEMANDS:

• Routine demands of an office-based environment

 
TRAVEL REQUIREMENTS:

• Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required.
• Requires approximately 20-30% travel.

 

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
 
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
 
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer. 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $90.00/hr.