Vice President, Quality Systems and Regulatory Affairs

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JOB DESCRIPTION

Imagine working for a truly global firm whose employees share a singular passion - to make the world a better place. Our client is a leading global biopharmaceutical company whose employees enjoy what they do. They are driven by a set of values and a common purpose – to improve the world we live in. Innovation is built into every project that they manage and every community they serve.

1) Lead the quality, safety and environmental management teams/systems to ensure compliance with all relevant and applicable regulations that oversee company’s business activities
2) Participate as a key member of the company executive team in developing and achieving near and long term business objectives
3) Develop resource strategies and planning for the QS & RA team
4) Ensure that company is prepared at all times to pass all external inspections, both from regulatory agencies and customers
5) Implement and maintain quality systems, including ongoing data analysis of product and process outputs to make sure early detection and response to quality concerns, and prevention of quality issues
6) Provide quality leadership oversight for all elements of the quality management system and safety/environmental management system
7) Establish and monitor performance metrics for executive team review, and to enable application of continuous improvement programs in the QMS/EMS
8) Identify continuous improvement opportunities throughout the organization by routinely reviewing site metrics, gathering customer data and other methods in an effort to optimize overall operational efficiency and effectiveness
9) Provide regulatory guidance to R&D to establish project plans that support best practice filing strategies of drug development pipeline projects
10) Participate with R&D during new product start-ups, and establish key checkpoints for new products and processes
11) Manage all aspects of plant quality system including, CAPA, supplier quality, change control, in-process quality assurance, quality control, complaint management and validation functions
12) Hire and manage departmental personnel directly and through subordinate managers and supervisors
13) Support an aggressive quality program which instill personal accountability for accuracy, consistency and completeness for all operations and departments according to site and corporate policies
14) Create and maintain an environment of excellence, world-class quality and continuous improvement throughout the entire plant
15) Provide primary contact and interface with all regulatory personnel and customer’s quality/EHS representatives
16) Review incoming regulatory agency correspondence, determine target period for response to review letters, and recommend regulatory strategies to comply
17) Provide guidance to R&D/product development teams and manufacturing groups and collaborate closely with other team members of the organization and to drive business growth
18) Identify the quality guidance for product development and manufacturing and defining the regulatory pathways for all markets
19) Provide approval or rejection of starting materials, packaging materials and intermediate, bulk and finished products as per the appropriate regulations and documents
20) Approve specifications, sampling instructions, test methods and other QC procedure
21) Coach and develop the team to high performance while fostering a culture of team ownership
22) Set clear vision to align company goals and objectives with business objectives
23) Provide leadership for employee relations through effective communications, coaching, training and development and create strategies to improve team performance
24) Supply the highest level of internal and external customer service
25) Lead team in continuous improvement activities and develop strategies for incorporating team input
26) Ensure proper maintenance and cleanliness of the department, premises and equipment
27) Measure and communicate team’s progress against individual, team and site goals
28) Author, approve and review area quality and safety exceptions and investigation reports
29) Ensure on-time completion of all corrective action items assigned to area
30) Verify, review and make appropriate changes to any controlled document pertinent to area of responsibility
31) Identify opportunities to reduce costs and risk, and improve service

CRITICAL REQUIREMENTS

  • 1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
    2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
    3) Recent experience in the biopharmaceutical industry is strongly preferred
    4) Preference will be given to people having recent experience in quality systems and regulatory affairs

    This could be an once-in-a-lifetime opportunity for the right person who is looking to make a positive career change. If you think this could be you, please apply!

COMPANY INFORMATION

Sterling-Hoffman is a retained executive search firm that specializes in representing life sciences and technology companies in matters of high impact talent acquisition. Our clients include market leaders and venture capital-backed startups in industries such as: medical device, biotechnology, pharmaceuticals, enterprise software, clinical research, and laboratory services. You may view more of our jobs here: http://www.sterlinglifesciences.com Your privacy is important to us: we will never share your resume without your permission. Please note that only qualified applicants will receive a response. We encourage you to apply for as many jobs as you believe you are a fit for, but strongly suggest that you include your salary information as job seekers who provide salary information are likely to be reviewed sooner. ===================== TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Biotechnology Recruiter, Pharmaceutical Recruiter, Medical Device Recruiter, Biotechnology Career, Clinical Research Job, Regulatory Affairs Job, R&D / Scientist Job, Product Manager Job, Medical Device Sales Job, Biotechnology Sales Job, Quality Assurance Job, Engineering Job, Laboratory Jobs, Microbiology Jobs, CEO Jobs, Marketing Jobs, Manufacturing Jobs, Oncology Jobs, Cardiology Jobs, Hematology Jobs, Medical Jobs

JOB INFORMATION

Seniority Level:
Director / VP
Function:
  Regulatory Affairs,  Quality
Preferred Industry Background:
  Pharmaceuticals
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation:
A superb base salary and bonus structure are available; compensation is commensurate with experience and will be discussed with qualified candidates only.
Education Required:
Any