Senior Specialist Quality Assurance Compliance

Job Description

#2124 Sr. Specialist, Regulatory Compliance - Quality

Description:

Ensures quality and compliance to domestic and international regulatory requirements through performance of internal and external audits and provides guidance and leadership to the site. Assists in the establishment of Company compliance strategy and facilitates resolution and prevention of compliance risks.

Responsibilities

Schedules and conducts internal audits of manufacturing operations, laboratories, warehouses, and support departments to ensure compliance with company, domestic (FDA, DEA, etc), and international regulatory requirements. Activities include:

• Conducting meetings with senior management to discuss audit observations and responses.
• other areas within the organization and develops action plans to address.
• Determining acceptability of responses, provides recommendations when appropriate, and monitors CAPAs to completion.
• Partnering with audited functional/operational area to perform root cause analysis of non-compliance in order to determine CAPA. Provides regulation based recommendations and support as needed to resolve quality/compliance issues. Evaluates effectiveness of CAPAs generated from internal audits.
• Preparing (with limited guidance) the annual internal audit schedule. Assesses regulatory environment, internal risks and industry trends/best practices for development of the internal audit schedule.

Partners with and influences Operations, Laboratories, Warehousing & Distribution, and Quality Assurance to ensure consistent compliance approach throughout the organization and support quality compliance adherence. Activities include:

• Leading cross-functional project teams (managing scope, deliverables, timelines, and team members).
• Interpreting and communicating domestic and international regulatory requirements (e.g. 21 CFR Parts 4, 11, 210, 211, 820, EMA, WHO, etc).
• Acting as resource for inquiries.
• Serving as Regulatory Compliance representative on teams or in meetings.
• Serving as subject matter expert (SME) in the development of GxP training programs.

Leads routine and Pre-approval Inspection (PAI) readiness activities (customer and regulatory) to ensure a consistent approach before, during, and after inspections. Activities include:

• Evaluating systems, processes and documentation for compliance to customer or regulatory requirements.
• Conducting meetings with area management to discuss preparation activities and documentation requests.
• Hosting customer inspections.
• Leading audit room or ready room operations.
• Obtaining and reviewing requested documentation.
• Preparing SMEs prior to interactions with authorities; and accompanying inspectors during facility tours.
• Leading development of audit responses including review with senior leadership.
• Prepares (with limited guidance) field alert reports and manages recall activities.

Schedules, coordinates, and conducts audits of suppliers who provide GMP related materials and services to ensure supplier compliance with domestic, international, and company requirements.

Facilitates cross-functional review of regulatory guidances or corporate policies.

• This role must engage with all other functional areas and must network and leverage relationships in Quality & Compliance locally, regionally, globally, and with external business partners as appropriate.
• Interacts with individuals within the organization who have different personalities, styles, expectations, and motivations.
• Leads cross-functional teams and/or initiatives. This role mentors others, including people leaders and individual contributors in other areas, as well as, other Regulatory Compliance specialists.

Qualifications

• BA/BS, preferably in scientific, engineering or quality field, is required. Other BA/BS programs may be considered provided that the applicant has successfully completed fundamental college math and science coursework.
• Five (5) years of pharmaceutical/regulated industry operations or quality experience required.
• Demonstrated proficiency in Regulatory requirements (cGMPs, DEA) and compliance including demonstrated knowledge of regulatory auditing principles.
• Demonstrated proficiency in computer skills as a business tool, including work experience with Microsoft applications (Word, Excel, PowerPoint, Outlook) and site systems (SAP, Trackwise, QSDB, and ARQ document management system).
• Experience in pharmaceutical manufacturing, packaging, and/or quality preferred.
• Experience and inspection interaction with State and Federal regulatory officials (i.e. FDA, DEA, or Board of Pharmacy) preferred.
• Auditing certification (ASQ, ISO or other recognized institute) preferred

Benefits

• Annual performance bonus potential
• 401k employer match up to 6% of your contributions
• 23 vacation/personal days
• 11 paid Company holidays
• Generous healthcare benefits
• Employee discount program
• Wellbeing rewards programs
• Safety and Quality is a top organizational priority
• Career advancement/growth opportunities
• Tuition Reimbursement
• Maternity and Parental Leave