Compliance Manager (Clinical)- Los Angeles, Ca – Direct Hire Direct Hire/ Full Time Employee

Employment Requirement: “In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.”

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JOB TITLE: Compliance Manager

LOCATION: Los Angeles, Ca

HIERARCHY/REPORT TO:  Assistant Director of Operations (ADO)

SALARY: To be discussed

DKKD Staffing has placed many people at this company over the years

PRIMARY FUNCTIONS: Having audit hosting experience either with an external pharma regulatory compliance group or an outside regulatory body/agency is beyond paramount due to the number of audits this person would be involved in hosting with its pharma clients.

Q&A with client: 

What have the challenges been in filling this so far?  Most candidates either don’t have clear audit hosting/inspection readiness experience, or they’re at a level where they aren’t going to be prepared and ready to roll-up their sleeves and be hands-on.

Must have vs wish list on the job description: – Must have – external Audit Hosting experience and strong level of understanding of the regulatory landscape both FDA (Title 21, Part 11 and other regulations per JDX) and be able and willing to be hands-on as a part of their managerial role,  pro-active participation in the daily compliance requirements and process.  Nice to have – several years of supervisory experience, managing staff.   Also, having exposure to other regulatory rules such as EU’s GDPR and ISO 9001, etc..see Jdx.

EDUCATIONAL EXPERIENCE, TRAINING (including Licenses and Professional Activities):
Education
o Bachelor’s degree required. Combined education and experience may be used as substitute for minimum education.
o Professional training in Clinical Trial Operations; FDA Regulations and ICH/GCP Guidelines for clinical research preferred.
o Certified Regulatory Compliance Manager (CRCM) preferred.
o CCRP or similar clinical research certification beneficial.

Experience
o 5 years of progressive management experience.
o Prior supervisory experience preferred
o Strong familiarity with CFR Title 21, ICH GCP, and GDPR
o Experience with ISO9001 beneficial
o 5+ years developing and implementing compliance programs in a laboratory or healthcare environment.
o Project management experience preferred
o Minimum of 4 years of progressively responsible professional experience required.
o Experience in multi-center clinical trials required.
o Familiarity with process and quality improvement principles (e.g. Six Sigma) preferred.
o 5+ years working in a clinical research environment
o Familiarity with software development and the software development lifecycle
o Expert level in standard Microsoft Office programs

JOB SUMMARY:

The Compliance Manager implements, maintains and continually improves the compliance function at the company’s corporate site. The Compliance Manager provides substantial input and oversight into a variety of projects and processes to insure adherence with all laws, regulations and contractual obligations that apply to the company’s corporate site. Acts as an advisor on custom software development projects and Commercial Off-The-Shelf Software (COTS) to ensure regulatory compliance. Collaborates with Quality Assurance and other departments as advisor on compliance issues for resolution. This position serves as the main interface with sponsor and regulatory auditors/inspectors.

DUTIES AND RESPONSIBILITIES
1. Supervises the compliance team (Percent of time: 20%)                                                                                                                                                                                                                                                                            a. Responsible for staffing, scheduling, interviewing and hiring, evaluating work performance, counseling, discipline, and termination. Participates in addressing employee grievances.
b. Provides daily direction, communication, training, and oversight to the team to ensure efficient productivity.
c. Monitors and negotiates the scope of the compliance work and commitments.
d. Monitors workflow to ensure adequate productivity and timely completion of projects. Notifies appropriate personnel of delays or problems which may affect timelines and/or deadlines.
e. Oversee study assignments and resourcing in conjunction with appropriate stakeholders.
f. Aids in the development of training programs for existing staff and new hires.
g. Mentors team personnel, including but not limited to:
i. Establishing timelines/expectations for training of individuals, and monitoring progress.
ii. Identifying training and learning opportunities for compliance team (e.g. technical training, educational programs, quality improvement projects), and involving or delegating to direct reports accordingly.
iii. Inviting team members to participate in meetings or teleconferences, both internal and external (e.g. setting up a study)
iv. Providing feedback for circumstances as observed on a day-to-day basis
v. Including team members in quality improvement and/or other ad hoc projects
vi. Knowledge and information sharing

2. Serves as a SME for Compliance, including but not limited to (Percent of time: 60%):
a. Oversees and provides direction for the Company’s regulatory compliance strategy and activities
b. Stay up-to-date with the latest developments in regulatory compliance, in particular as relates to the company.
c. Maintains an expert level understanding of any and all laws, regulations and contractual obligations that apply to the company.
d. Act as the primary point of contact for external regulatory compliance audits from sponsors and regulatory agencies and is responsible for related inspection readiness activities at the company. Prepare responses to external compliance audit observations, and works in coordination and collaboration with impacted stakeholders to address audit findings and in accordance with internal procedures/policies.
e. Accountable for the following:
i. Establish and implement overall compliance program.
ii. Establish and implement corrective action preventative action (CAPA) program.
iii. Establish and implement non-conformance program.
iv. Establish and implement  internal audit program.
v. Establish and implement  management review program.
vi. Establish and implement risk management program.
vii. Establish and implement supplier audit program.
viii. Establish and implement validation master plan.
ix. Establish and implementation of additional policies and procedures as Process Owner including but not limited to Good Documentation Practices (GDP), Protected Health Information, General Data                            Protection Regulation (GDPR) Method Validation,
f. Responsible to review/approve changes controls, and other critical processes within the company as Compliance Authority.
g. Provides collaborative input to the quality assurance function related to continuous quality improvement (CQI) concepts and goals.
h. Reviews, edits, and provides technical and compliance input on study-related documents to ensure that documentation adheres to SOP/Regulation requirements. Provide feedback in a timely manner.
i. Provides compliance direction for software development projects undertaken within the company, particularly in the area of software validation and lifecycle management. Provides direction on requirements, best practices and related documentation/records/systems necessary to promote compliance with 21 CFR Part 11.
j. In collaboration with senior management, establishes policies and procedures consistent with regulatory requirements and industry standards in order for the company to maintain compliance to applicable laws, regulations, standards, and official guidance.
k. Develops, presents, and/or delegates staff training modules addressing regulatory compliance.
l. Develops and manages corrective action plans (CAPAs) for resolution of problematic issues related to Compliance. Performs risk analysis related to noncompliance. Note: the QA manager will also issue and manage CAPAs related to quality issues within the overall CAPA program.

Other Tasks – Percent of time: Ongoing
3. Communicates with other department teams to oversee, coordinate, and ensure study commitments/timelines are met.
4. Performs other projects or tasks as assigned by the ADO or Administrative Director in support of the overall goals of the company. May include both project support tasks and general operations support.
5. Attending meetings as SME:
a. Attending sponsor calls
b. Attending investigator meetings
c. Conferences and courses for various reasons:
i. Business development
ii. Imaging technology
iii. Pursuing opportunities to improve upon supervisorial skills.
iv. Pursuing opportunities to acquire or improve upon technical knowledge.
6. Perform all tasks in a safe manner in compliance with company safety policies and according to applicable regulations. Maintain a neat work station and environment. Dress in appropriate and professional manner. Maintain clean, neat and acceptable personal attire for job duties. (Percent of Time: Ongoing)
7. Display courtesy and consideration to patients, guests, physicians and staff. (Percent of Time: Ongoing)
8. Maintain confidentiality of all records and information which pertains to patients, physicians, employees, the organization and in related interests. (Percent of Time: Ongoing)

SUPERVISION:
Functions independently with minimal supervision of the  Administrative Director. Supervises compliance staff.
EDUCATIONAL EXPERIENCE, TRAINING (including Licenses and Professional Activities):
Education
o Bachelor’s degree required. Combined education and experience may be used as substitute for minimum education.
o Professional training in Clinical Trial Operations; FDA Regulations and ICH/GCP Guidelines for clinical research preferred.
o Certified Regulatory Compliance Manager (CRCM) preferred.
o CCRP or similar clinical research certification beneficial.

Experience
o 5 years of progressive management experience.
o Prior supervisory experience preferred
o Strong familiarity with CFR Title 21, ICH GCP, and GDPR
o Experience with ISO9001 beneficial
o 5+ years developing and implementing compliance programs in a laboratory or healthcare environment.
o Project management experience preferred
o Minimum of 4 years of progressively responsible professional experience required.
o Experience in multi-center clinical trials required.
o Familiarity with process and quality improvement principles (e.g. Six Sigma) preferred.
o 5+ years working in a clinical research environment
o Familiarity with software development and the software development lifecycle
o Expert level in standard Microsoft Office programs

Abilities and Characteristics
o Strong quality and ethics orientation
o Able to recognize the stakeholders in the clinical trial process, and the priorities of different stakeholders
o Excellent critical thinking skills
o Strong organizational skills
o Ability to evaluate problems from multiple sides and critically consider multiple alternate solutions
o Ability to communicate effectively with management and staff
o Ability to independently make administrative decisions in the best interest of the department, when necessary
o Ability to supervise, develop, and train staff.
o Excellent writing and editing skills.
o Solid understanding of statistical concepts and methods, college-level math skills (algebra, trigonometry, etc.)
o Can work independently with minimal supervision.
o Can handle multiple tasks simultaneously, assess and shift priorities effectively.
o Has excellent follow through skills.
o Has strong attention to detail.
o Can foster a cooperative work environment.
o Proficient in the use of Microsoft Word, Excel, PowerPoint, and Outlook.
o Can interpret policies and procedures and to apply standards consistently.
o Can appropriately handle confidential and sensitive information.
o Can interface well with all departments and within the organization to represent department overall in a highly professional manner.