Senior Manager, Quality Systems - Complaints

PAI Holdings LLC • Greenville, SC

6d • Onsite

About The Position

PAI Pharma has been at the forefront of producing better-targeted suspensions, oral solutions, elixirs, syrups, and liquids for nearly 50 years. PAI Pharma's mission is to participate in the creation of healthier lives by exceeding the expectations of those we serve with innovative treatments.

PAI Pharma has an extensive product portfolio including over the counter and prescription solutions, elixirs, syrups, and semi-solids. To meet the unique needs of retail chains and independent pharmacies, hospitals, long-term care facilities and government agencies, PAI Pharma offers standard bottle packaging and ready-to-dispense unit-dose packaging.

PAI Pharma also develops original formulations and new drug delivery systems governed by a strict quality validation process. We strive to offer more user-friendly formulations in more enticing flavors. Our core strength is in pharmaceutical ingredients, dosage form, and analytical chemistry of generic medicines and wellness products.

JOB SUMMARY:
The Senior Manager, Quality Systems- Complaints and Document Control will report directly to the Sr Director of Quality. This is a unique position to the organization, as it will provide oversight of the PAI Pharma complaint and document management processes, and support deviations and change controls. This role will:

• Controls and manages security, accessibility, availability, verification, proper distribution and timeliness of organizational documents and material that may benefit and be used to get information on policies, procedures, regulations, methods, templates and training materials.

• Develop and provide updates to a document management plan.

• Manges and maintain organizational documentation through the complete document life cycle.

• Serve as the final quality review of all complaint investigations and procedural reviews.

• Drive standardized implementation of the assigned quality processes across the site, including Document Control or Complaints while supporting Change Control, Deviations, & CAPA

• Leads the development and enforcement of documentation design, review, and storage guidelines,

• Manages, assigns and approves document user privileges.

• Plans and conducts training and presentations for Quality programs, (Quality Council, SPL, Cares Act, PPSWG)

• Quality management of the SAP system for Quality input and inspection programs

• Primary leader point of contact and subject matter expert for development and migration to any new IT platforms for complaints and document control.

• Lead the Review Boards to document change requests and complaint processes and coordinate with all functional leaders to ensure accuracy and completeness of information and metrics.

Ensure adherence to policies and procedures and identify and implement tools and training to continuously improve the quality systems;

Develop and implement complaint and document management procedures, work instructions and training to maintain compliance to current standards and regulations, as well as identify and implement process improvements; and

• Collaborate with all impacted stakeholders to ensure that changes are agreed upon and effectively implemented.

Requirements

• 10+ years of quality system experience is required; Regulatory Affairs experience is preferred.
• Bachelor’s degree in related medical, science, or regulatory discipline required.
• 12+ years of experience in the pharmaceutical industry in a quality role.
• 7+ years of experience in leading quality system management processes.
• 7+ years of experience in management of quality sub-systems at a functional level – responsible QA for ownership, development, improvement, and accountability.
• 7+ years of experience with cGMP quality system regulations and investigations.
• 10+ years of experience working with and collaborating with cross-functional teams.
• Demonstrated strong proficiency with Microsoft systems (Excel, PowerPoint, Word, and Project) and Agile.
• Excellent verbal and written communication skills, including attention to detail; strong questioning and listening skills; and the ability to look beyond obvious answers to understand the impact on other areas is required.
• Strong influencing, negotiations and leading without direct line authority experience is required.
• Significant detail in good documentation practices and training mechanisms, and ability to drive timelines across multiple functional groups and leaders, with minimal management oversight/direction.
• Must have ability to make effective presentations to all levels of the organization.
• Must have the ability to work in both a collaborative (team) environment as well as perform independent work as required.
• The proven ability to prioritize and manage multiple projects and meet deadlines is required.

Nice To Haves

• Experience with Six Sigma Process Excellence tools, training and/or certification is a plus.
• Experience with documentation and technical writing skills, in a regulated compliance environment, is preferred.
• ASQ Certifications for Auditing and/or Quality Management is preferred.

Responsibilities

• Participate directly in establishing strategic direction for quality system activities that are aligned with business and quality initiatives and in compliance with all regulatory requirements.
• Develop, implement, and maintain procedures and work instructions to support the administration of the quality system and manage the learning management program and curricula
• Recommend and implement quality system processes improvements driven by new regulations, industry standards, new technologies, and internal business needs.
• Maintain current knowledge of, and compliance with, the full range of related quality systems, technology, regulatory requirements, and related policies and procedures.
• Prepare and participate in compliance program, customer and internal audits, regulatory inspections, and QMS assessments.
• Ensure adequate training is conducted and competency is maintained among key process stakeholders.
• Participate in external and internal regulatory compliance inspections.
• Participate in Management Review meetings as required.

Benefits

• Excellent benefits including On-Site Wellness Clinic, health, dental, vision, STD/LTD, and life insurance, HSA with employer contribution, 401(k) and Roth 401k, Employee Assistance Program (EAP), Allstate Plans: Accident – Cancer – Critical Illness, paid holidays and PTO.
• Excellent compensation package pending experience and qualifications.

What This Job Offers

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