We**Apply on the website**;re looking for a candidate to fill this
position in an exciting company.
* Fostering a right-first-time culture across operations.
* Develop short and long-term plans to achieve both quality and
* Emphasize the critical need for on-time delivery through the lens
of full compliance, driving this focus across all levels of the
* Ensuring inspection readiness of operations, including preparation
to regulatory inspections
* Interface directly with FDA, EMA and other regulatory authorities
and ensure the company is appropriately represented in matters related
to compliance and quality, especially in communications with the
* Develop resource strategies, allocate budget, staff, tools and
specialized support necessary for efficient operations.
* Assess and progress an unparalleled Quality System on site in
alignment with the PSG Quality Policy and Corporate policies and
standards as a key differentiator for the organization.
* Optimize the Quality organizational model with the objective of
increasing our customer focus and value; aligning roles and
* Translate the API business strategy to programs and goals for the
function; ensure execution and delivery of such programs.
* Collaborate with Operational and Functional peers to formulate
short and long-term quality objectives for the site, establish a
quality plan, related KPIs and accountability measures by which
performance can be assessed regularly across the Quality Function.
* Use scientific judgment to develop solutions, and drive risk
analysis and mitigation strategies.
* Maintain awareness of all escalated Quality matters and exercise
sound, risk-based decision making in addressing these issues, working
closely with the GM, Quality leaders, Legal and Business Relationship
Management teams when concerns arise.
* Ensure appropriate and efficient systems are in place for
investigation and follow-up of non-conformances and quality issues,
such as complaints, deviations, OOS results, or audit observations;
ensure timely closure of any corrective and preventative actions.
* Accountable for the development, maintenance and management of
quality systems that conform to applicable cGMP regulations.
* Coach and guide the Quality team to ensure that the above
activities are implemented and aligned across the business globally.
* Maintain influential relationships with clients and suppliers.
* Establish effective relationships with peer GMs, site leads and
functional leaders to ensure sharing of best practices, sound
application of strategic goals, leveraging of "expertise," and
alignment for our clients as a global business.
* Bachelor**Apply on the website**;s degree in a life science
discipline, advanced degree highly preferred.
* Minimum of **Apply on the website** years related progressive
experience, to include a minimum of 5 years of people
management/direct leadership experience. Understanding of the API
manufacturing process in GxP environments.
* Fluent in English, written and oral is crucial.
* Considerable hands-on experience interacting with health
authorities, especially related to regulatory inspections and
* Experience managing within a matrix environment. Demonstrated
ability to collaborate and navigate across the globe effectively with
solid business results.
* Strong influencing skills, internally and externally, demonstrated
within prior work environments.
_EXPERIENCE WORKING_ effectively with clients in regulated
* Excellent communication skills, ability to build productive
* Strong drive to challenge thus improve processes continuously.
* Strong problem-solving skills and the ability to make timely,
* Focus on patient needs and a client-centric mindset.
* Demonstrated success in coaching teams through internal and
external challenges, preferably in a matrixed culture.
* Multi-cultural exposure and understanding; experience to work in
and with global teams.
_ABILITY TO_ lead, motivate and influence others within a remote team.
Highly talented at team building, coaching and mentoring with a
passion for inspiring others at all levels of the organization.
* Experience in developing others through personalized development
plans with a track record of developing future leaders.
* Strong leadership skills with the ability to get the buy-in of
* Track record of achieving results and proven ability to clearly
identify and communicate a cogent vision; effectively manage through
ambiguity and uncertainty, take appropriate risks and make sound and
* Embodies our Thermo Fisher values of Integrity, Involvement,
Intensity and Innovation.
_ABILITY TO_ travel based on business needs up to **Apply on the
website**%, international and domestic travel.
We need : English (Good)