Director of RA/QA: High-Growth, R&D, and Manufacturing Life Sciences org – Western OR

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Our client, an international R&D and manufacturing Life Sciences organization is experiencing exciting growth internationally and boasts a team of top-tier scientists and researchers; an intellectually driven, yet fun and enjoyable culture; and leading-edge innovation. Beyond a compelling growth opportunity, they offer attractive and generous bonuses and full benefits which bears out in the happiness and long retentions of their employees. The Director of Regulatory and Quality will oversee all aspects of regulatory affairs, quality control and assurance activities, ensuring the operation of company laboratories and organization are efficiently managed and perform to optimum levels.

The Director of Regulatory and Quality will lead an exceptionally collaborative, bright young demographic and build their growing cohesive global quality team. This is a rare and exciting ground floor opportunity for a hands-on strategist who likes to build and affect change, who is ready for a challenge and an international career leadership growth opportunity.

The organization is located in a highly desirable area: close to mountains, bucolic wine country, and stunningly rugged Oregon Coast.  The area has top ranked schools, an impressive array of restaurants, coffee shops, breweries, and easy access to outdoor fun. Acumen has hired many stellar candidates who have been delighted with their relocation to the area.

If you:

Have a track record of providing leadership, vision, and setting the strategic and tactical direction to the QC, QA, and other teams.
Can plan independently and work collaboratively.
Have an ability to influence, build, and maintain strong collaborative relationships, while holding all stakeholders accountable for regulatory and quality standards; meeting timelines, while honoring all commitments, and targets, both internally and externally.
Possess a solid working knowledge of Global Quality Management Systems and how they are developed and implemented to meet DEQ/EPA, DOT, IATA, City, State, OSHA, FDA, EMA, MHRA, GMP and GLP standards/requirements.
Are accustomed to successfully hosting regular audits.
Can establish and accept final accountability for and decision making on matters relating to cGMP global manufacturing compliance for the site.
Have experience developing, implementing, and executing strategic plans and objectives for the quality organization, and collaborating with the executive team on critical delivery initiatives.
Demonstrate exceptional customer interface skills, responding with agility and a methodical approach, meeting organizational targets by gaining buy-in from necessary stakeholders.
Experienced in domestic and global regulatory filings and in leading related inspections and audits for US and foreign regulatory agencies
We would love to speak with you about your next potential career step.

Our client company is looking to add senior leadership to their growing executive team within the Regulatory/Quality Department. This position requires a true leader of people, with experience in solving problems through collaboration and bringing chemistry from development into manufacturing. A person who can take the lead to identify, establish, and evaluate the key business drivers for success (metrics) of the business for the department in order to achieve continued growth in revenue, regulatory approvals, efficiency, cost management, high quality of products, and satisfied customers

As the Director of Regulatory and Quality you will be responsible for:

Planning and overseeing all aspects of Regulatory/Quality affairs, ensuring compliance with all regulatory agencies and leading teams and company in continuous process improvement.
Excellent analytical, decision making and problem-solving skills with superior managerial skills, someone that can be a mentor coach.
Able to model a positive image of the organization, responsible for guiding company culture by articulating mission, vision, values and clearly defining program goals gaining buy-in from clients/peers.
Preparing, reviewing, and implementing: Standard Operating Procedures, work instructions, Chemical Hygiene Plan, Quality Manual, Laboratory Health and Safety Program.
Leadership, and setting strategic and tactical direction of multiple small teams, including working with other team leaders to lead all things regulatory and quality throughout product lifecycle, for rapid movement through the quality process into clinical trials to manufacturing.
Leading unified coordination/integration of efforts among operations, engineering, technology, quality, and customer service divisions.
Managing and developing EQMS system for Global Regulatory/Quality Validation.
Providing oversight to the on-going maintenance of Quality system procedures; ensuring that changes to the procedures are consistent with the intended structure of the Quality System.
cGMP manufacturing, domestic and global regulatory filings and a ‘rolodex’ in leading product related inspections and audits for US and foreign regulatory agencies.
Managing the execution of all efforts targeted at fulfilling strategies to help clients and company achieve desired outcome.
Partnering with critical suppliers to maintain the highest rate of supplier performance and compliance.
Influence, build, and maintain strong collaborative relationships, while holding all stakeholders accountable for regulatory and quality standards, meeting timelines, while honoring all commitments, and targets, both internally and externally.
Providing oversight to the on-going maintenance of Quality system procedures; ensuring that changes to the procedures are consistent with the intended structure of the Quality System.
Exceptional communication skills to explain new directives, policies to management; Meeting with entire operations staff to field questions, identify concerns and gain buy-in and willing adoption
Administration of all aspects of manufacturing, purchasing, and quality departments to ensure compliance in all areas. Strategic quality insight regarding product development plans.
Familiar with Change Management concepts able to implement policy and procedural changes.
Requirements:

High level of organization and systems skills, collaborative, and solution oriented.

Minimum of a bachelor’s degree in a science or engineering discipline.
Minimum 4-5 years’ experience
Extensive and diversified manufacturing experience in regulatory and quality departments.
Familiarity with Lean Manufacturing concepts.
Thorough understanding of practices, theories, and policies involved in laboratory and manufacturing operations.
Self-motivated, driven, and able to work with little supervision for organizational success.
Strong leadership skills and ability to motivate others to work as a team towards a common goal, and a strong balance of strategic and tactical approaches, team building, training, coaching and development.
Proven success in executing improvement plans and activities that achieve expected results.
Strong verbal and written communication skills. Superior managerial and diplomacy skills.
Ability to communicate at all levels of the organization in order to influence change and drive system improvements to meet customer requirements.
To apply please send cover/resume to: Molly@AcumenExecutiveSearch.com.

Keywords: Clinical, Regulatory, Regulatory Affairs, RA, Quality, RA/QA, QA, QC, GMP, Audits, Compliance, Manager, Director, Leadership, Life Sciences, FDA, MHRA, EMA, FDA, Manufacturing, Engineering, Global, Quality System Regulation, HPFB, Health Canada, Lean Manufacturing, Lean, Engineering, EU, EQMS, QMS, Strategic Plan, Operations, Project Management. Leadership, Communication, Collaboration

To apply for this job please visit www.acumenexecutivesearch.com.