Senior Director, Quality

Summary:

This role will provide organizational management and leadership to the Quality Assurance functions in support of commercial manufacturing and release. The position includes responsibility for the refinement of the corporate quality strategy, working in collaboration with the Global Head of Quality and other senior management, to ensure compliance with pertinent regulations, standards and clinical guidelines.

Essential Duties & Responsibilities:
The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.

1. Provide leadership and direction for the Quality Compliance of products developed, produced, tested, and released for pre-clinical, clinical and commercial use.
2. Drive the quality activities for the Quality Management System (QMS) implementation across the Organization and ensure contract manufacturer(s) are in compliance.
3. Foster a culture of continuous improvement, excellence, professional integrity and respect for patient safety, ensuring that all necessary management systems are in place to make these high principles actionable and the compliant practices result in the Company's ultimate medical and commercial success.
4. Provide strategic direction and guidance to Executive Management regarding quality timelines for new and revised products and/or processes, and/or regulations & guidance's.
5. Establish, maintain and monitor ongoing Company-wide quality and compliance policies with applicable regulatory agencies, and other international quality compliance requirement for other countries including reporting, records, training, systems and processes that ensure the Company's quality system is functioning properly.
6. Ensure all cGMP required validation and/or qualification is performed on processes, equipment, utilities and facilities to support the Company's regulatory licensing requirements.
7. Develop department plans, strategies and budgets that are aligned with company goals and objectives.
8. Provide leadership support in organizing activities associated with Regulatory and partner inspections.
9. Ensure clinical studies are conducted in alignment with the Guidance for Good Clinical practice.
10. Collaborate with Regulatory Affairs in preparation of filings and submissions, as well as prepare responses to agency requests for information.
11. Ensure US disposition of finished product for Commercial and Clinical use is in alignment with applicable regulatory guidelines.
12. Ensure appropriate disposition of Raw Material for commercial and clinical use.
13. Ensure appropriate leadership is notified of significant Quality issues and appropriate actions are taken.
14. Ensure US Authorities are notified of Quality issues in alignment with appropriate regulations.

Supervisory Responsibilities:
This role has supervisory responsibilities.

Interaction:
The position works closely with executive leadership, Manufacturing, Engineering, Product Development, Clinical, Pharmacovigilance, Commercial and Regulatory Affairs. In addition, the individual interacts outside the company with partners, suppliers, regulatory agencies and professional groups.

Education and Experience:
* 15 years of relevant pharmaceutical experience required
* BS degree in a related field required

Qualifications:
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.

Knowledge, Skills, and Abilities:

1. Ability to manage multiple responsibilities with a high degree of self-motivation
2. Strong oral, written, and interpersonal English communication skills
3. Strong technical presentation skills
4. Demonstrated planning, organizing and executions skills
5. Demonstrated strong leadership and managerial skills

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse. Will need to lift and move items weighing up to 20 pounds.

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

The work setting is consistent of a typical pharmaceutical manufacturing environment with production areas, offices, and cubicles.

• 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

The base pay range for this role in California is $171,200 per year to $225,000 per year.
The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications.

EEO Statement: Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law. At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.
Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.