Head Of Quality Assurance

Role Overview

Extensive background in drug safety, compliance, and risk management. Possess a solid grasp of pharmacovigilance in various clinical phases, post-marketing, and quality control. Value added skills in leading cross functional teams, managing projects, and fostering collaborative relationships with regulatory bodies. Adapt in analyzing data, creating/presenting reports, and leveraging technological advancements to optimize PV operations. Committed to driving continuous improvement initiatives.

Areas of Responsibility

• Pharmacovigilance Leadership, Review and approve validation protocols as required.
• Develops, implements, and manages processes to ensure that products meet required specifications for quality, function, and reliability prior to delivery.
• Communicates quality standards and parameters to QA team and other appropriate staff.
• Staying current on laws and regulations to ensure compliance.
• Working with suppliers to ensure the quality of supplies.
• Maintains compliance with federal, state, local, and organizational laws, regulations, guidelines, and policies.
• Formulate strategies to increase quality and productivity.
• Function as a catalyst for change and improvement in performance and quality.
• Regulatory compliance, cross functional Collaboration.
• Quality Management systems, Promotional and Marketing Oversight.
• Develop and execute a strategy for vendor oversight, while maintaining strong vendor relationships.
• Foster a culture of continuous improvement by providing pivotal support to Quality Leads.
• Optimized decision making at executive level through detailed analysis and communication of Quality review results to committees, governance bodies and senior leaders.
• Other duties as assigned.

Other Responsibilities Including Safety: Complies with all job-related safety and other training requirements.

Requirements

Education & Qualification:

- Bachelor’s Degree in Life science with 7-9 years of relevant experience within the pharmaceutical or healthcare industry.

- Minimum 3-4 years of experience in pharmaceutical GMP- regulated industries (biotech preferred).

- Must have working knowledge of FDA and ex-USA regulatory requirements pharmaceutical industry quality systems.

- In-depth knowledge of cGMP, FDA regulations (21 CFR Parts 211, 212), ICH & QC regulations.

Certifications, Licenses, Credentials: N/A

Skills & Ability

- Windows, MS Office, ASM Online (Training Records), TWMS, CRS (Corporate Reporting System), MAXIMO, Concerto.

- Focus on diverse responsibilities, performance tracking and evaluation.

- Strong team leadership, managerial and communication skills.

- Able to maintain a professional and positive attitude.

- Team Building, project & business analysis, Procedure Development.

- Able to maintain confidentiality and possess a high level of ethics and integrity.

Physical Requirements (lifting, etc.):

The employee is frequently required to sit (50%), stand, and walk (50%). Uses hands to finger, handle or feel writing tools and computer keyboard. May reach with hands and arms and infrequently may lift up to 30lbs. Use desk telephone/cell phone to talk and hear or converse with other employees.

Work Environment (Office, Warehouse, temperature extremes, etc.):

Primarily located in an office environment where temperatures are controlled for heat and air conditioning; occasionally walks through warehouse or manufacturing workplace and will be required to wear appropriate PPE for each work area including safety shoes, hair net, safety glasses, face mask, gloves, or disposable jumpsuit.

Job Type: Full-time

Pay: $70.00 - $72.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 5 years

Schedule:

• Monday to Friday

Work setting:

• In-person
• Office
• Warehouse

Work Location: In person