Associate Director, Clinical Quality Compliance

Overview:

About Pacira

Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.

Be part of our movement, let’s pursue excellence together.

The primary responsibilities for this role are to execute the annual Clinical Quality Compliance Audit Plan, develop and maintain the Clinical vendor/supplier list and qualify new vendors/suppliers and CRO’s.

Responsibilities:

• Develop the CQC annual Audit Plan and maintain the Clinical vendor/supplier list in collaboration with the Head of Clinical Quality/other functions, as appropriate.
• Identify, plan, schedule, and conduct external GCP / GVP audits of Clinical Investigator sites, Clinical vendors/suppliers, CROs, and internal systems/process audits in accordance with the annual Audit Plan.
• Initiate audit follow-up activities, including the review and approval of audit responses to ensure appropriate CAPA plans are in-place to address both internal and external audit findings. Facilitate the development of CAPA plans in relation to Clinical Investigator site deviations, Clinical study/protocol deviations, and/or internal process deviations, providing feedback and coaching, when necessary.
• Provide Quality Assurance oversight to Clinical Development functions to ensure compliance with applicable regulatory requirements associated with Pacira Clinical Development programs.
• Support global Regulatory Agency inspections and audits conducted at Pacira and at clinical investigator’s sites.
• Develop, author and revise departmental Standard Operating Procedures (SOPs) and serve as reviewer and approver of functional SOPs to ensure quality and regulatory compliance.
• Ensure compliance with current global Regulatory standards, as well as internal standards, policies, procedures, and processes in all audit activities, departmental initiatives/projects and day-to-day interactions with Clinical Development colleagues.
• Support global Regulatory Agency inspections in various capacities and ensure completion of Regulatory Agency commitments resulting from these inspections.
• Act as the quality liaison for ongoing and planned clinical programs and Clinical Development functions
• Identifying and support internal process improvement initiatives such as Inspection Readiness activities (e.g., Mock Inspections, Mock Inspection interviews, and Gap Assessments) and any other Quality/Operational initiatives.
• Other duties as assigned

Supervisory Responsibilities: This role does not have supervisory responsibilities.

The incumbent works closely with Quality Assurance, Clinical Operations, Medical Strategy, Pharmacovigilance, Clinical Data Management, Data Operations & Standards, Biostatistics and Programming, Clinical Supply Operations, Medical Writing, Regulatory Affairs, Medical Affairs and external consultants, GCP vendors/suppliers, business partners, and other Pacira service providers, as needed.

Qualifications:

• 10 years of relevant Pharmaceutical Industry experience with a minimum of 8 years of GCP Quality Assurance experience required
• BS/BA degree required (scientific discipline desirable)

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to manage multiple projects and responsibilities independently and simultaneously, with limited supervision, with emphasis on high priorities and sensitive timelines required by Regulatory Agency/Health Authority requirements and/or Clinical program or Clinical study milestones and timelines
• Strong knowledge and application of ICH GCP guidelines, GVP regulations and US-FDA, EU-EMA, and UK-MHRA regulations for medicinal products
• Ability to use Microsoft Office and other QMS applications
• Ability to prioritize and manage multiple responsibilities with a high degree of enthusiasm, discipline, self- motivation, accuracy, and when required, a strong sense of urgency
• Good written, oral, and interpersonal communication skills

May regularly sit, talk, move between spaces, reach with hands and arms and stoop. Regularly focus on a computer screen and use hands, fingers and wrists to type on keyboard and manipulate mouse. Commonly lift and move boxes of paper and binders weighing up to 20 pounds.

Typical office setting, cubicles, noise level is moderate with consistent printer, telephone ringing and conversation. The position requires approximately 25-50% travel consisting of both domestic and international.

Benefits:

Benefits:

• Medical, Prescription, Dental, Vision Coverage
• Flexible Spending Account & Health Savings Account with Company match
• Employee Assistance Program
• Mental Health Resources
• Disability Coverage
• Life insurance
• Critical Illness and Accident Insurance
• Legal and Identity Theft Protection
• Pet Insurance
• Fertility and Maternity Assistance
• 401(k) with company match
• Flexible Time Off (FTO) and 11 paid holidays
• Paid Parental Leave