A Situational Leadership Challenge
A Situational Leadership
Challenge
Background of the Study
• A large pharmaceutical manufacturer was highly motivated to meet quality challenges. They implemented an ISO 9000-compatible quality system to ensure not only FDA compliance requirements, but also customer satisfaction. As the manufacturing plants of the organization were audited by the internal audit division, it became apparent that some plants were meeting the challenge while others continued to struggle in both the quality and the regulatory aspects of production. For the most part, the manufacturing plants share consistent resources and face similar environments. All understood the consequence of not conforming-that is, jeopardizing their manufacturing license as bound by the consent decree.
Problem Solver/Viewpoint
• The CEO, as the leader of the plant, who has the responsibility of ensuring the successful implementation of a quality system is the problem solver of the issue.
Statement of the Problem
• The issue is why some pharmaceutical manufacturing plants could successfully design and implement the requirements of the quality system while others could not and still cannot.
Statement of the Objective
• To shed light on the issue, our main goal is to answer these three questions:
1.
2.
3.
What leadership competencies are most critical for success in pharmaceutical organizations?
How strong are current pharmaceutical leaders in the competencies most critical to success?
What potential pitfalls lie ahead?
Areas of Consideration
The following are the basis on being an effective leader.
• Leadership Competencies
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
Building a collaborative relationship
Strategic perspective
Taking initiative
Participative management
Leading employees
Change management
Decisiveness
Being a guide study
Composure
Self-awareness
Respect for differences
Career management
Compassion and sensitivity
Balance between personal work and life
Confronting problem
Challenge
Background of the Study
• A large pharmaceutical manufacturer was highly motivated to meet quality challenges. They implemented an ISO 9000-compatible quality system to ensure not only FDA compliance requirements, but also customer satisfaction. As the manufacturing plants of the organization were audited by the internal audit division, it became apparent that some plants were meeting the challenge while others continued to struggle in both the quality and the regulatory aspects of production. For the most part, the manufacturing plants share consistent resources and face similar environments. All understood the consequence of not conforming-that is, jeopardizing their manufacturing license as bound by the consent decree.
Problem Solver/Viewpoint
• The CEO, as the leader of the plant, who has the responsibility of ensuring the successful implementation of a quality system is the problem solver of the issue.
Statement of the Problem
• The issue is why some pharmaceutical manufacturing plants could successfully design and implement the requirements of the quality system while others could not and still cannot.
Statement of the Objective
• To shed light on the issue, our main goal is to answer these three questions:
1.
2.
3.
What leadership competencies are most critical for success in pharmaceutical organizations?
How strong are current pharmaceutical leaders in the competencies most critical to success?
What potential pitfalls lie ahead?
Areas of Consideration
The following are the basis on being an effective leader.
• Leadership Competencies
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
Building a collaborative relationship
Strategic perspective
Taking initiative
Participative management
Leading employees
Change management
Decisiveness
Being a guide study
Composure
Self-awareness
Respect for differences
Career management
Compassion and sensitivity
Balance between personal work and life
Confronting problem