Inspection Readiness Specialist

Haleon • Town of Durham, NY

2d • $110,178 - $151,494

About The Position

The purpose of the Quality Inspection Readiness Specialist role is to support the site before, during, and after regulatory inspections from Regulatory Agencies such as FDA. Internal Corporate and Third-Party audits and to ensure audit readiness at all times. This includes supplier and service provider auditing as well as the oversight and maintenance of the internal audit program at the site. Support the site Inspection Readiness program including coordination of internal and external audits and inspections. Manages site audit plan, including issuing audit reports and communication to managers; tracks audit commitments and manages monthly reporting. Prepare Inspection Readiness plans for regulatory agency inspections, corporate and customer audits. Responsible for supporting inspections at the site Manages the internal audit program Stays current with all relevant Federal, state, and corporate regulations, guidelines, and policies and industry trends. Supports regulatory queries from different markets. Manages the Supplier and Service Provider required audits Establish a series of stretching, measurable improvement processes and metrics across the department which will be tracked to add value to both internal and external customers. Provide responsibility for other quality, product, and/or compliance activities as assigned.

Requirements

• Bachelor’s degree in science or relevant field and 5 years of experience in a regulated GMP industry

Nice To Haves

• Knowledge of cGMP’s/FDA and other Regulatory requirements such as ICH Guidelines 8, 9, 10, 11.
• Demonstrate initiative and analytical problem-solving skills – ability to use and interpret data to drive decision making at both tactical and strategic level.
• Requires project management and leadership skills.
• Ability to work well under high pressure and deadlines
• Must be flexible, adaptable, and a strong team player and a leader that fosters teamwork and promotes Company Values, Behaviors and Strategies.
• Excellent verbal and written communication skills required.
• Conflict resolution and interaction management skills required

Responsibilities

• Enhance the site inspection readiness program by: ensuring cross-functional inclusion of key SMEs are occurring to keep the site in ready inspection mode at all times; maintaining a frequently evaluated ‘top issues’ list of topics to be prepared to speak to during an inspection; ensuring frequent Gembas of the processes to understand the current state for any emerging top issues.
• Manage and Support FDA and other regulatory inspections for the site; write and coordinate the issuance of a timely response to the Agency for any observations; and manage completion of commitments.
• Host Internal Corporate; write and coordinate the issuance of a timely response for any observations, including follow-up reports.
• Manage internal commitments to ensure timely follow-up and completion as committed to the audit functions.
• Maintain Site Internal Audit and Self-Inspection programs.
• Communicate effectively and establish processes to ensure smooth communication within the department, across functions and across sites.
• Ensure two-way communications between Site Leadership and the department.
• Approve GMP related documentation such as SOPs, CCs, Deviation, Validation/Qualification documents and Technical Reports.
• Approves any changes associated with these documents.

Benefits

• Competitive pay
• Generous 401(k) plan
• Tuition reimbursement
• Time off programs
• 6 months paid parental leave
• Healthcare programs where the company pays for the majority of your medical coverage for you and your family
• Opportunity to receive a discretionary bonus based on the achievement of key business performance
• Other incentive/recognition programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level