Manager, Quality and R/A
What You Will Do In Your Role
- Holds the responsibility and oversight for product and facility regulatory filings and submissions, reporting activity, consulting, and regulatory agency communications.
- Serves as a key customer and regulatory interface as needed to assist in business development.
- Defines, communicates, and gains cross functional and cross-site support for the quality system and compliance strategy to mitigate product and compliance risk.
- Establishes the site Quality KPIs and for RA and compliance metrics.
- 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.
- Forecasts headcount and resource needs based on priorities.
- Drives and delivers global and regional quality initiatives in manufacturing site.
- Leads the quality system management, validation, risk management, product quality planning and monitoring throughout the whole product lifecycle.
- Leads the supplier quality management.
- Provides quality leadership of adverse event investigations and issues related to customer complaints.
- Partners with others to drive costs out of the business and lower operating expense, drives the continual improvement/innovation in quality team.
- Actively participates in key quality initiatives such as the Global Quality Council; Regional Councils; and subject matter expertise forums.
- Other duties as assigned.
The Experience You Will Bring
- Minimum of a bachelor’s degree with a concentration in quality, engineering, or life science (e.g. chemistry, microbiology).
- Should have direct expert knowledge in both medical device and pharmaceutical RA product submission lifecycle activities.
- 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.
- 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.
- Significant experience in an overall cGMP / GXP operating environment.
- Open minded, embrace challenge and transformation.
- A strategic and tactical person with the ability to build positive relationships at all levels.
- Strong technical and problem-solving skills required.
- Strong written, verbal, organizational, and interpersonal communication skills.
- Project management skills.
- Ability to work in a fast-paced work environment that is matrixed globally.
- 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.
- Creative and effective challenge of the status quo when developing and recommending solutions.
- Fluent English in writing & spoking.