Lead, Operations QA & Compliance - Remote
Posted on: June 24, 2022
Location: Princeton, NJ
Job Type: Full Time - Regular
Description And Requirements
JOB SUMMARY: Responsible for establishing and maintaining quality
assurance standards and measures across WCG services organizations
and ensuring such standards comply with regulatory requirements and
best practice. This position is responsible for working alongside
WCG leadership to achieve corporate and departmental compliance
goals as well as ensuring the CSO organization remains compliant
with the Quality Management System and business processes.
To be considered for U.S.-based positions unless currently employed
by WCG, where permitted by applicable law (including any applicable
reasonable accommodation, medical or religious exemption),
candidates must have received or be willing to receive the COVID-19
vaccine by start date.
- Bachelor's degree in a relevant discipline required, or
equivalent combination of education and experience.
- Certifications for quality professionals through the Society
for Quality Assurance, American Society for Quality or comparable
certifications are desirable.
- Minimum of five (5) years' experience in a quality/regulatory
compliance position, with a proven track record of success in
leading/managing quality assurance projects/assignments, and
- A minimum of three (3) years' experience in establishing and
monitoring compliance standards across a business unit including
analysis and tracking.
- Prefer a minimum of two (2) years' supervising the work of
others to complete key initiatives and projects.
- A satisfactory progression of auditing experience from support
to execution an hosting, in a pharmaceutical company or Client
Research Organization (CRO).
- Thorough knowledge of current regulatory and GCP guidelines as
they apply to document management practices in clinical trials and
- Minimum of one (1) year experience in ISO certification is
- Will conduct presentations on behalf of WCG. Strong
presentation skills required.
- Strong MS Office skills required.
- Strong organizational and planning skills.
- Strong management skills with a proven record to influence and
- Effective communication (written and oral) skills,
organization, and interpersonal skills as well as the ability to
interact with WCG personnel, clients, and regulatory agencies as
- In-depth knowledge and understanding of the clinical trial
- Highly developed problem-solving skills and the ability to
resolve difficult conflicts.
- Ability to work efficiently and independently.
To perform this job successfully, an individual must be able to
perform each essential duty and responsibility
satisfactorily. The requirements listed below are representative of
the knowledge, skills, and/or ability
- Engage in the continued development, maintenance, and
enforcement of the CSO Quality Management System.
- Manage/lead efforts in the identification, development and
maintenance of CSO quality goals, objectives, and process
- Establish and enforce CSO quality department objectives.
- Coach and train WCG staff on CSO quality department standards
and best practices.
- Engage with WCG staff to author, revise and implement internal
standards and associated documents.
- Lead the development of new processes or updates to existing
- Ensure such standards are in conformity with applicants'
regulatory agency regulations and guidance.
- Ensure such standards are made available to employees for
- Manage the integration, implementation and/or development of
- Serve as the subject matter expert with respect to
harmonization of processes and procedures.
- Lead the transition of computerized systems for WCG acquisition
companies into the WCG framework, as applicable.
- Manage the implementation, development and release of
controlled documents to ensure same is performed in line with
industry standards, and regulatory agency regulations and guidance,
including but not limited to GxP, GDPR, and HIPPA.
- Manage/lead the investigation of Quality Events/ Corrective
Actions Preventative Actions (CAPA), deviations, and notes to file
- Ensure proper investigation of such events is performed, and
- Manage/troubleshoot issues reported by personnel.
- Manage, lead and conduct internal audits to ensure internal
standards and staff performance follow applicable WCG process,
industry standards and regulatory agency regulation and
- Manage/lead the conduct of internal audits/periodic review of
WCG processes and procedures.
- Identify compliance gaps and provide support and suggestions
for remediation. Report status of the quality levels of staff,
systems and production activities to the VP, Operations QA &
- Conduct external vendor qualification audits to ensure that
vendor standards and performance follow applicable WCG process,
regulatory agency regulation and guidance.
- Develop vendor audit plans, reports, collection of responses
and follow up.
- Host external audits and inspections, including communication
with client/agency, internal audit preparation activities, review
of audit report, collection of response and follow up on findings
- Maintain current knowledge with respect to quality legislation
and regulatory compliance best practice.
- Provide training and guidance regarding compliance and
interpretation of regulations.
- Ability to work independently across functional resources with
- Other duties as assigned by supervisor. These may, on occasion,
be unrelated to the position described here.
- Attendance and punctuality are essential functions of the
- Must be able to work additional hours as needed for special
projects and audits.
TRAVEL REQUIREMENTS: 20%
WCG is proud to be an equal opportunity employer - Qualified
applicants will receive consideration for employment without regard
to race, color, national origin or ancestry, religion or creed,
sex, sexual orientation, gender identity, age, marital status,
disability, genetic information, citizenship, veteran status,
reprisal or any other legally recognized basis or status protected
by federal, state or local law.
Keywords: WCG, Trenton , Lead, Operations QA & Compliance - Remote, Other , Princeton, New Jersey
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