Compliance Specialist - III (Senior)

Job Title: Compliance Specialist - III (Senior)Duration: 12-Month ContractLocation: Onsite - 727 Norristown Rd Building 2, Spring House Innovation Park, Lower Gwynedd Township, PA 19002Hours: Monday to Friday, 8:00 AM - 5:00 PMEducation:

Bachelor’s degree in Quality Assurance, Engineering, Chemistry, Biology, Compliance, or a related discipline.

Formal Quality Training, including statistical process control or a quality-related qualification, is a plus.

Qualifications/Experience:

Minimum of 10 years of professional experience in compliance, regulatory affairs, or a related field.

Extensive knowledge and understanding of relevant regulations, particularly in the biotherapeutic industry (e.g., FDA 21CFRs).

Proven experience in managing compliance programs, policies, and procedures.

Skills and Competencies:

Strong attention to detail, with the ability to review technical documentation for accuracy and completeness.

Experience conducting compliance audits, investigations, and risk assessments.

Familiarity with developing and implementing compliance training programs.

Ability to develop and maintain relationships with regulatory authorities, where applicable.

Strong knowledge of compliance frameworks, best practices, and industry standards.

Proficiency in risk management methodologies, with the ability to identify and mitigate compliance risks.

Excellent analytical, problem-solving, and communication skills.

Proficiency in using compliance software tools and systems.

High-level proficiency in Excel, Word, PowerPoint, Outlook, and LIMS.

Responsibilities:Compliance Audits:

Conduct audits of scientist/engineer records and lab systems to ensure completeness, accuracy, and compliance with established standards.

Audit department records and processes related to bioanalytical data and lab systems, including feedback surveys, after-action reviews, and lab documentation.

Identify opportunities to improve the quality and efficiency of records and processes.

Prepare and present audit findings, recommendations, and corrections to internal leadership.

Participate in the preparation, facilitation, and follow-up activities for regulatory and accreditation surveys.

Compliance Analytics:

Utilize tools and methods to organize, catalog, and analyze auditing data, generating metrics and tracking analytics.

Interpret and monitor metrics to identify trends and ensure compliance with auditing goals and benchmarks.

Prepare and present analytics to internal leadership and external audiences.

Department Support:

Serve as the department's Compliance Expert, providing coaching, mentoring, and training on documentation best practices.

Lead performance improvement projects and collaborate on quality initiatives across the organization.

Participate in department committees and workgroups, and contribute to business continuity planning and remediation efforts.

Requirements:

Proven ability to communicate, collaborate, and work effectively with cross-functional teams.

Ability to adapt to a dynamic work environment and handle multiple tasks with precision.

Must have strong collaboration skills with team members and stakeholders.

If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson WellsManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.