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**Position:** Lead Compliance Officer

**Location:** Onsite (Pharmaceutical Manufacturing Facility)

**Salary Range:** $75,000 – $85,000+ (DOE)

**Bonus:** Bi-annual cash bonuses

Overview

Are you passionate about leading compliance initiatives in a dynamic pharmaceutical environment? We are seeking a Lead Compliance Officer to establish and drive compliance strategies across all operations, reporting directly to the General Manager. This is a unique opportunity to build and develop a compliance team, establish standards from the ground up, and ensure adherence to FDA and other regulatory frameworks.

You'll collaborate closely with Quality Assurance, Quality Control, and Manufacturing teams, and be instrumental in shaping the direction of our compliance program. We're looking for a proactive, adaptable leader who thrives in building new processes and excels in GMP environments.

Key Responsibilities

+ Develop and implement compliance programs centered around cGMP operations.

+ Conduct regular assessments and audits for internal departments and third-party providers.

+ Identify areas for improvement; collaborate with stakeholders during strategic planning.

+ Lead notifications regarding regulatory changes affecting operations.

+ Oversee responses and communication with regulatory agencies.

+ Analyze regulatory developments and industry trends; make recommendations to enhance compliance strategies.

+ Respond to inquiries, assist with inspections, and ensure timely reporting to authorities.

+ Champion compliance training programs for employees, ensuring comprehensive understanding of regulatory requirements.

+ Collaborate across departments to address compliance and support holistic risk management.

+ Perform internal audits; ensure adherence to company policies and applicable regulations.

+ Oversee accurate documentation of manufacturing processes.

+ Drive corrective and preventive actions to address compliance gaps.

+ Foster a collaborative work environment; encourage professional growth and team knowledge sharing.

+ Monitor and evaluate employee performance; provide constructive feedback.

+ Oversee departmental staffing needs, conduct interviews, and select qualified candidates.

+ Additional responsibilities as assigned.

Qualifications

+ Minimum 8 years' experience in pharmaceutical, analytical testing, or related science field

+ Minimum 3 years in pharmaceutical compliance or quality assurance

+ Bachelor’s Degree in Biological Sciences, Chemistry, Biomedical Engineering, or relevant field (preferred)

+ Comprehensive knowledge of GxP, FDA, ICH, OSHA requirements; 21 CFR Part 11 familiarity

+ Experience building compliance programs and teams strongly preferred

+ Proficient with Microsoft Office applications

+ Strong organizational skills and excellent attention to detail

+ Effective communicator; able to work independently and as part of a team

+ Experience working in ambiguous GMP environments preferred

+ Physically able to sit, stand, squat, kneel, walk for prolonged periods; lift up to 25 lbs on occasion

Competencies

+ Independent work ethic

+ Analytical problem-solving

+ Quality and results-driven mindset

+ Decision-making proficiency

+ Technical aptitude and thoroughness

Work Environment

Operates primarily in a controlled laboratory setting with standard office equipment. Requires frequent standing and walking, as well as the use of protective gear (mask, gloves, gown, hairnet, goggles).

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Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

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