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Manager, Quality and R/A

Description


What You Will Do In Your Role

  1. Holds the responsibility and oversight for product and facility regulatory filings and submissions, reporting activity, consulting, and regulatory agency communications.
  2. Serves as a key customer and regulatory interface as needed to assist in business development.
  3. Defines, communicates, and gains cross functional and cross-site support for the quality system and compliance strategy to mitigate product and compliance risk.
  4. Establishes the site Quality KPIs and for RA and compliance metrics.
  5. Provides direction and leadership to the Quality group including people management as follows: Talent acquisition; Talent development; Performance management; Employee communication, ensuring team is aligned with and accomplishing goals/objectives; administrative processing; and, maintaining trust and confidentiality while fostering a team environment.
  6. Forecasts headcount and resource needs based on priorities.
  7. Drives and delivers global and regional quality initiatives in manufacturing site.
  8. Leads the quality system management, validation, risk management, product quality planning and monitoring throughout the whole product lifecycle.
  9. Leads the supplier quality management.
  10. Provides quality leadership of adverse event investigations and issues related to customer complaints.
  11. Partners with others to drive costs out of the business and lower operating expense, drives the continual improvement/innovation in quality team.
  12. Actively participates in key quality initiatives such as the Global Quality Council; Regional Councils; and subject matter expertise forums.
  13. Other duties as assigned.

    The Experience You Will Bring

    Requirements:

    1. Minimum of a bachelor’s degree with a concentration in quality, engineering, or life science (e.g. chemistry, microbiology).
    2. Should have direct expert knowledge in both medical device and pharmaceutical RA product submission lifecycle activities.
    3. Minimum 10 years’ experience in Quality/Compliance environment with at least 5 plus years demonstrated leadership in quality role driving best practices and developing high performing teams in a multi-site global manufacturing environment.
    4. Minimum 5 years of proficient experience with the following regulatory/notified body requirements: FDA CFR Part 11, part 820; Part 210 and 211; ISO 9001:2015; 13485:2016; NMPA and EU Medical Device Regulations is a plus.
    5. Significant experience in an overall cGMP / GXP operating environment.
    6. Open minded, embrace challenge and transformation.
    7. A strategic and tactical person with the ability to build positive relationships at all levels.
    8. Strong technical and problem-solving skills required.
    9. Strong written, verbal, organizational, and interpersonal communication skills.
    10. Project management skills.
    11. Ability to work in a fast-paced work environment that is matrixed globally.
    12. Demonstrates a high level of technical skills, sound engineering judgment, technical writing skills, statistical skills, and critical thinking in product development activities and resolution of quality issues.
    13. Creative and effective challenge of the status quo when developing and recommending solutions.
    14. Fluent English in writing & spoking.


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