Sr Director Quality Assurance - Bridgewater, United States - BioSpace

BioSpace Bridgewater, United States

3 weeks ago

Description

Job Details

Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions

Named Science's Top Employer in 2021, 2022, and 2023

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in BiopharmaTM, Best Workplaces in New YorkTM, and Best Workplaces for MillennialsTM lists.

Overview
Reporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical/Clinical Departments. The incumbent will provide support and promote collaboration internally and externally to ensure all systems, processes and their outcomes comply with applicable international and national standards, regulations, and guidelines in partnership with Drug Safety and Pharmacovigilance (DSPV) representative.
Responsibilities
Additional representative responsibilities will include, but not necessarily be limited to, the following:

Facilitate and maintain a risk-based and scientific-based quality system to support Good Pharmacovigilance Practice (GVP).
Establish and maintain Pharmacovigilance inspection readiness in collaboration with DSPV subject matter expert (SME) and act as company's representative during regulatory agency inspections and vendor audits.
Ensure that a risk-based audit plan is developed, designed and implemented, and that the activities are conducted, reports written according to SOPs and that QEs/CAPAs are written, reviewed and followed up.
Structure and conduct internal Pharmacovigilance systems audits
Supports the evaluation and acceptability of Pharmacovigilance vendors for potential use and provides direction, guidance and strategicconsultation for the company.
Conduct external audits on PV vendors, CROs, Specialty Pharmacies and monitoring organizations with responsibility for writing audit reports along with reviewing and monitoring QE's/CAPAs.
CQA representative for review of PV SOPs/WIs, PSMF, SDEA's, JOGs and other PV related documents.
Supports strategic direction with cross functional working groups to identify and mitigate GVP quality and compliance issues/risks.
Provide support and training to other staff members to develop additional GVP expertise in quality and auditing resources.

Qualifications:

Minimum BS degree in Chemistry or related life sciences discipline required with minimum 10-15 years of experience, 7 years of which are in Pharmacovigilance.
Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience will be considered.
Requires solid experience with pharmacovigilance in Phases I-IV (particularly Phase III) and post-marketing.
Experience with effectively managing regulatory agency inspection and working with regulators and internal staff to help prepare for inspections is required.
Strong knowledge and understanding of drug and device FDA, EU and ICH regulations, pharmacovigilance regulations/processes and HA inspection procedures is required.
Experience developing SOPs, reviewing internal pharmacovigilance, clinical, regulatory, and medical processes to ensure they are accurately represented in current SOPs is essential.
CQA representative on weekly/monthly pharmacovigilance meetings.
Ability to organize and conduct internal audits is necessary.
Ability to conduct external audits on PV vendors, CROs, Specialty Pharmacies and monitoring organizations with responsibility for writing audit reports as well as reviewing and tracking CAPAs.
Broad knowledge of risk-based quality systems approaches consistent with post-marketing Good Pharmacovigilance Practices and ICH E-6 for Good Clinical Practice.
Must successfully exhibit Insmed's five (5) core values of: Passion, Respect, Integrity, Accountability and Collaboration.

#LI-KM#LI-Hybrid
Qualifications

Minimum BS degree in Chemistry or related life sciences discipline required with minimum 10-15 years of experience, 7 years of which are in Pharmacovigilance.
Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience will be considered.
Requires solid experience with pharmacovigilance in Phases I-IV (particularly Phase III) and post-marketing.
Experience with effectively managing regulatory agency inspection and working with regulators and internal staff to help prepare for inspections is required.
Strong knowledge and understanding of drug and device FDA, EU and ICH regulations, pharmacovigilance regulations/processes and HA inspection procedures is required.
Experience developing SOPs, reviewing internal pharmacovigilance, clinical, regulatory, and medical processes to ensure they are accurately represented in current SOPs is essential.
CQA representative on weekly/monthly pharmacovigilance meetings.
Ability to organize and conduct internal audits is necessary.
Ability to conduct external audits on PV vendors, CROs, Specialty Pharmacies and monitoring organizations with responsibility for writing audit reports as well as reviewing and tracking CAPAs.
Broad knowledge of risk-based quality systems approaches consistent with post-marketing Good Pharmacovigilance Practices and ICH E-6 for Good Clinical Practice.
Must successfully exhibit Insmed's five (5) core values of: Passion, Respect, Integrity, Accountability and Collaboration.

#LI-KM

#LI-Hybrid

Travel Requirements

Ability to travel both domestically and internationally, approximately 25%-30%.

Salary Range
Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees.

The base salary range for this job is from $200,000.00 to $280,000.00 per year
Compensation & Benefits

We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

Flexible approach to where and how we work
Competitive compensation package including bonus.
Stock options and RSU awards
Employee stock purchase plan
401(k) plan with company match
Professional Judgment Vacation Policy
11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day).

ADDITIONAL U.S. BENEFITS:

Medical, dental, and vision plans
Company-provided short- and long-term disability plans
Company-provided life insurance
Unique offerings of pet, legal, and supplemental life insurance
Flexible spending accounts for medical and dependent care
Accident and Hospital Indemnity plans
Supplemental AD&D
Employee Assistance Program (EAP)
Mental Health on-line digital resource
On-site, no-cost fitness center at our U.S. headquarters
Paid time off to volunteer

#LI-KM

#LI-Hybrid

Additional Information

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Applications are accepted until the position is filled.

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